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AzTrials

Coronary Artery DiseaseABSORB IINCT01425281

ABSORB II Randomized Controlled Trial

A study testing Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System and Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System in people with Coronary Artery Disease, run by Abbott Medical Devices at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE) Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System and Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
501 participants
Where
1 siteBelgium
Study dates
Nov 2011to 23 May 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • Subject must be at least 18 years of age and less than 85 years of age.
  • Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure. This includes clinical trials of medication and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
  • Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS system and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
  • Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia).
  • Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
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  • Subject must agree to undergo all clinical investigation plan-required follow-up visits, exercise testing, blood draw as well as adherence to European Society of Cardiology Guidelines and completion of quality of life questionnaires and of a subject diary to collect information including but not limited to tobacco usage, food intake, daily exercise and body weight
  • Angiographic Inclusion Criteria
  • One or two de novo native lesions each located in a different epicardial vessel.
  • If two treatable lesions meet the eligibility criteria, they must be in separate major epicardial vessels (left anterior descending (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
  • Lesion(s) must have a visually estimated diameter stenosis of ≥50% and <100% with a TIMI flow of ≥1.
  • Lesion(s) must be located in a native coronary artery with Dmax by on-line quantitative coronary angiography (QCA) of ≥2.25 mm and ≤3.8 mm.
  • Lesion(s) must be located in a native coronary artery with lesion(s) length by on-line QCA of ≤48 mm.
  • Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥30 days prior to or if planned to be done 2 years after the index procedure.
  • Percutaneous intervention for lesions in the target vessel are allowed if done >6 months prior to or if planned to be done 2 years after the index procedure.

Who cannot join

  • Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  • Subject has a known diagnosis of acute myocardial infarction (AMI) at any time preceding the index procedure and relevant cardiac enzymes (according to local standard hospital practice) have not returned within normal limits at the time of procedure.
  • Evidence of ongoing acute myocardial infarction in ECG prior to procedure
  • Subject has current unstable arrhythmias.
  • Left ventricular ejection fraction (LVEF) < 30%.
  • Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
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  • Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
  • Subject is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
  • Subject is receiving chronic anticoagulation therapy that can not be stopped and restarted according to local hospital standard procedures.
  • Elective surgery is planned within 2 years after the procedure that will require discontinuing either aspirin, clopidogrel, prasugrel or ticlopidine.
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Known renal insufficiency (e.g., estimated glomerular filtration rate <60 ml/kg/1.73m² or serum creatinine level of >2.5 mg/dL, or subject on dialysis).
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past 6 months.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
  • Other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
  • Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
  • Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.
  • Angiographic Exclusion Criteria
  • Target lesion which prevents adequate (residual stenosis at target lesion(s) is ≤ 40% by visual assessment) coronary pre-dilatation.
  • Target lesion in left main trunk.
  • Aorto-ostial target lesion (within 3 mm of the aorta junction).
  • Target lesion located within 2 mm of the origin of the LAD or LCX.
  • Target lesion located distal to a diseased (vessel irregularity per angiogram and >20% stenosed lesion) arterial or saphenous vein graft.
  • Target lesion involving a bifurcation lesion with side branch ≥2 mm in diameter, or with a side branch <2mm in diameter requiring guide wire protection or dilatation.
  • Total occlusion (TIMI flow 0), prior to wire crossing
  • Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90 °) proximal to or within the target lesion.
  • Restenotic from previous intervention
  • Heavy calcification proximal to or within the target lesion.
  • Target lesion involves myocardial bridge.
  • Target vessel contains thrombus as indicated in the angiographic images.
  • Additionally clinically significant lesion(s) (≥ 40% diameter stenosis by visual assessment) for which percutaneous coronary intervention may be required <2 years after the index procedure.
  • Subject has received brachytherapy in any epicardial vessel (including side branches)
  • Subject has a high probability that a procedure other than pre-dilatation and study device implantation and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Abbott Vascular International BVBA

    Brussels, 0886.537.933

Other trials in Belgium

About this study

Official title: ABSORB II RANDOMIZED CONTROLLED TRIAL A Clinical Evaluation to Compare the Safety, Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Against XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by de Novo Native Coronary Artery Lesions

Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)

Read the detailed description

In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale in the US.

Being tested
Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Keywords
Bioabsorbable, Coronary scaffold, Coronary Stent, Everolimus, Drug eluting stents, Angioplasty, Coronary artery disease, Total coronary occlusion, Coronary artery restenosis, Stent thrombosis, Myocardial ischemia, Coronary artery stenosis
Medical subject headings
Coronary Artery Disease, Coronary Restenosis, Myocardial Ischemia, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abbott Vascular XIENCE Everolimus Eluting Coronary Stent SystemDevice

    XIENCE implantation in the treatment of coronary artery disease.

  • Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold SystemDevice

    ABSORB BVS implantation in the treatment of coronary artery disease.

Study groups in NCT01425281
Study groupRoleWhat they receive
XIENCE™Active comparatorAbbott Vascular XIENCE Everolimus Eluting Coronary Stent System
Receives: Device: Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
ABSORB BVS™ExperimentalExperimental: Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Receives: Device: Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)

    In-scaffold:Within the margins of the scaffold.

    Measured: 3 years

  2. Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter

    In-scaffold:Within the margins of the scaffold.

    Measured: 3 years

Secondary outcomes (104)

  1. Device Success

    Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).

    Measured: From the start of index procedure to end of index procedure

  2. Number of Participants With Procedural Success

    Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay.

    Measured: From the start of index procedure to end of index procedure

  3. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: In-hospital (≤ 7 days of post index procedure)

  4. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 30 days

  5. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 180 Days

  6. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 1 year

  7. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 2 years

  8. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 3 years

  9. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 4 years

  10. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 5 years

  11. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.

    Measured: In-hospital (≤ 7 days of post index procedure)

  12. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.

    Measured: 30 days

  13. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 180 days

  14. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 1 year

  15. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 2 years

  16. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 3 years

  17. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 4 years

  18. Number of Participants With All Myocardial Infarction (Per Protocol Definition)

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 5 years

  19. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: In-hospital (≤ 7 days of post index procedure)

  20. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: 30 days

  21. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: 180 days

  22. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: 1 year

  23. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: 2 years

  24. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: 3 years

  25. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: 4 years

  26. Number of Participants With Target Lesion Revascularization (TLR)

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

    Measured: 5 years

  27. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: In-hospital (≤ 7 days of post index procedure)

  28. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: 30 days

  29. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: 180 days

  30. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: 1 year

  31. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: 2 years

  32. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: 3 years

  33. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: 4 years

  34. Number of Participants With Target Vessel Revascularization (TVR)

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Measured: 5 years

  35. Number of Participants With Non Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: In-hospital (≤ 7 days of post index procedure)

  36. Number of Participants With Non Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 30 days

  37. Number of Participants With Non Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 180 days

  38. Number of Participants With Non Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 1 year

  39. Number of Participants With Non Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 2 years

  40. Number of Participants With Non Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 3 years

  41. Number of Participants With Non Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 4 years

  42. Number of Participants With Non-Target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

    Measured: 5 years

  43. Number of Participants With All Revascularization

    Revascularization:

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.

    Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.

    Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: In-hospital (≤ 7 days of post index procedure)

  44. Number of Participants With All Revascularization

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 30 days

  45. Number of Participants With All Revascularization

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 180 days

  46. Number of Participants With All Revascularization

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 1 year

  47. Number of Participants With All Revascularization

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 2 years

  48. Number of Participants With All Revascularization

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 3 years

  49. Number of Participants With All Revascularization

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 4 years

  50. Number of Participants With All Revascularization

    Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Measured: 5 years

  51. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: In-hospital (≤ 7 days of post index procedure)

  52. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI)

    • Q wave MI Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 30 days

  53. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI)

    • Q wave MI Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 180 days

  54. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 1 year

  55. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 2 years

  56. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 3 years

  57. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI)
    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 4 years

  58. Number of Participants Experiencing All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI)
    • Q wave MI Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 5 years

  59. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: In-hospital (≤ 7 days of post index procedure)

  60. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 30 days

  61. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 180 days

  62. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 1 year

  63. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 2 years

  64. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 3 years

  65. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 4 years

  66. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 5 years

  67. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: In-hospital (≤ 7 days of post index procedure)

  68. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 30 days

  69. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 180 days

  70. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 1 year

  71. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 2 years

  72. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 3 years

  73. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 4 years

  74. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 5 years

  75. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: In-hospital (≤ 7 days of post index procedure)

  76. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 30 days

  77. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 180 days

  78. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 1 year

  79. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 2 years

  80. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 3 years

  81. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

    Measured: 4 years

  82. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

    Measured: 5 years

  83. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization

    Measured: In-hospital (≤ 7 days of post index procedure)

  84. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization.

    Measured: 30 days

  85. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization.

    Measured: 180 days

  86. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization.

    Measured: 1 year

  87. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization.

    Measured: 2 years

  88. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization.

    Measured: 3 years

  89. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization

    Measured: 4 years

  90. Number of Participants With DMR (All Death, All MI, All Revascularization)

    DMR is the composite of All Death, All MI, All Revascularization

    Measured: 5 years

  91. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

    Measured: In-hospital (≤ 7 days of post index procedure)

  92. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 30 days

  93. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 180 days

  94. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 1 year

  95. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 2 years

  96. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI)

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 3 years

  97. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 4 years

  98. Number of Participants Experiencing Cardiac Death/All MI

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Measured: 5 years

  99. Number of Participants With Acute Stent/Scaffold Thrombosis

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window

    -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.

    Measured: <=1 day

  100. Number of Participants With Subacute Stent/Scaffold Thrombosis

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window

    -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.

    Measured: > 1-30 days

  101. Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window

    -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.

    Measured: 0-30 days

  102. Number of Participants With Late Stent/Scaffold Thrombosis

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window

    -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.

    Measured: 31-365 days

  103. Number of Participants With Very Late Stent/Scaffold Thrombosis

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window

    -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.

    Measured: > 365 days

  104. Number of Participants With Cumulative Stent/Scaffold Thrombosis

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent\&presence of at least 1 of the following criteria within a 48-hour time window

    -Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise\&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis\&in the absence of any other obvious cause.

    Measured: 0-1853 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJul 2016
  4. Study completion23 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01425281
Sponsor's protocol ID
10-393
Other IDs
CIV-11-10-002627
Acronym
ABSORB II
Status last verified
Jul 2019
First submitted
25 Aug 2011
Last updated
13 Nov 2019
Data monitoring committee
Yes

Publications

  • Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.

    PubMed 31561250

  • Grundeken MJ, White RM, Hernandez JB, Dudek D, Cequier A, Haude M, van Boven AJ, Piek JJ, Helqvist S, Sabate M, Baumbach A, Suwannasom P, Ishibashi Y, Staehr P, Veldhof S, Cheong WF, de Winter RJ, Garcia-Garcia HM, Wykrzykowska JJ, Onuma Y, Serruys PW, Chevalier B. The incidence and relevance of site-reported vs. patient-reported angina: insights from the ABSORB II randomized trial comparing Absorb everolimus-eluting bioresorbable scaffold with XIENCE everolimus-eluting metallic stent. Eur Heart J Qual Care Clin Outcomes. 2016 Apr 1;2(2):108-116. doi: 10.1093/ehjqcco/qcv022.

    PubMed 29474621

  • Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.

    PubMed 29089314

  • Serruys PW, Katagiri Y, Sotomi Y, Zeng Y, Chevalier B, van der Schaaf RJ, Baumbach A, Smits P, van Mieghem NM, Bartorelli A, Barragan P, Gershlick A, Kornowski R, Macaya C, Ormiston J, Hill J, Lang IM, Egred M, Fajadet J, Lesiak M, Windecker S, Byrne RA, Raber L, van Geuns RJ, Mintz GS, Onuma Y. Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. J Am Coll Cardiol. 2017 Jul 4;70(1):60-74. doi: 10.1016/j.jacc.2017.05.028.

    PubMed 28662808

  • Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iniguez A, Sabate M, Windecker S, Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016 Nov 19;388(10059):2479-2491. doi: 10.1016/S0140-6736(16)32050-5. Epub 2016 Oct 30.

    PubMed 27806897

  • Sotomi Y, Ishibashi Y, Suwannasom P, Nakatani S, Cho YK, Grundeken MJ, Zeng Y, Tateishi H, Smits PC, Barragan P, Kornowski R, Gershlick AH, Windecker S, van Geuns RJ, Bartorelli AL, de Winter RJ, Tijssen J, Serruys PW, Onuma Y. Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents: Intravascular Ultrasound Assessment From the ABSORB II Trial. JACC Cardiovasc Interv. 2016 Jun 27;9(12):1216-1227. doi: 10.1016/j.jcin.2016.03.022. Epub 2016 Jun 20.

    PubMed 27339838

  • Suwannasom P, Sotomi Y, Ishibashi Y, Cavalcante R, Albuquerque FN, Macaya C, Ormiston JA, Hill J, Lang IM, Egred M, Fajadet J, Lesiak M, Tijssen JG, Wykrzykowska JJ, de Winter RJ, Chevalier B, Serruys PW, Onuma Y. The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial. JACC Cardiovasc Interv. 2016 Jun 27;9(12):1231-1242. doi: 10.1016/j.jcin.2016.03.027. Epub 2016 Jun 1.

    PubMed 27262861

  • Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.

    PubMed 26825231

  • Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.

    PubMed 26585622

  • Ishibashi Y, Muramatsu T, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Cho YK, Garcia-Garcia HM, van Boven AJ, Piek JJ, Sabate M, Helqvist S, Baumbach A, McClean D, de Sousa Almeida M, Wasungu L, Miquel-Hebert K, Dudek D, Chevalier B, Onuma Y, Serruys PW. Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent. JACC Cardiovasc Interv. 2015 Jul;8(8):1053-1063. doi: 10.1016/j.jcin.2015.06.001.

    PubMed 26205444

  • Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015 Jan 3;385(9962):43-54. doi: 10.1016/S0140-6736(14)61455-0. Epub 2014 Sep 14.

    PubMed 25230593

  • Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, Chevalier B. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J. 2012 Nov;164(5):654-63. doi: 10.1016/j.ahj.2012.08.010.

    PubMed 23137495

Questions about this trial

What is this clinical trial studying?

A study testing Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System and Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System in people with Coronary Artery Disease, run by Abbott Medical Devices at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01425281, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.

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