AzTrials
AzTrials

Coronary Artery DiseaseABSORB CHINANCT01923740

A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

A study testing XIENCE V EECSS and Absorb BVS System in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Abbott Medical Devices at 1 site in United States.

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

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
XIENCE V EECSS and Absorb BVS System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteUnited States
Study dates
Jul 2013to 7 Mar 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be at least 18 years of age at the time of signing the informed consent form.
  • Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
  • Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
  • Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Female subject of childbearing potential does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 14 days (≤14 days) prior to the index procedure per site standard test.
  • Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
  • Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure.

Who cannot join

  • Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure.
  • Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  • Subject has a known allergic reaction, hypersensitivity or contraindication to:
  • Aspirin; or
  • All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or
  • Heparin and bivalirudin.
Show all 64Show fewer
  • Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure.
  • Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  • Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following criteria is met:
  • Subject requires coumadin or any other agent for chronic oral anticoagulation.
  • Subject likely to become hemodynamically unstable due to their arrhythmia.
  • Subject has poor survival prognosis due to their arrhythmia.
  • Subject has a known left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
  • Subject has received CABG at any time in the past.
  • Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure.
  • Subject requires future staged PCI either in target or non-target vessels.
  • Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  • At the time of screening, the subject has a malignancy that is not in remission.
  • Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  • Subject has previously received or is scheduled to receive radiotherapy to coronary artery (vascular brachytherapy), or chest/mediastinum.
  • Subject is receiving or will receive chronic anticoagulation therapy (e.g., coumadin or any other anticoagulation agents).
  • Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  • Subject has a known or documented hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • Subject has known renal insufficiency as defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
  • Subject is high risk of bleeding; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months; will refuse blood transfusions.
  • Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months or any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
  • Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the subject if radial or brachial access can be used.
  • Subject has life expectancy < 2 years for any non-cardiac cause or cardiac cause.
  • Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint or protocol-required medications or invasive procedures.
  • Angiographic Inclusion Criteria
  • Assessment of angiographic eligibility is per visual assessment by an investigator both for qualitative and quantitative variables. On-line QCA is recommended to be used for appropriately sizing of the vessel. If on-line QCA cannot be used, visual estimation is required.
  • One or two de novo target lesions:
  • If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
  • If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria.
  • The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.
  • Target lesion must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.
  • Target lesion must have a Dmax (by on-line QCA) or reference vessel diameter (RVD) (by visual estimation) ≥ 2.50 mm and ≤ 3.75 mm (on-line QCA assessment is recommended).
  • Target lesion must have a lesion length ≤ 24 mm based on either visual estimation or on-line QCA.
  • Angiographic Exclusion Criteria
  • All exclusion criteria apply to the target lesion(s) or target vessel(s). All exclusion criteria are based on visual estimation.
  • Target lesion is located in left main.
  • Aorto-ostial RCA target lesion (within 3 mm of the ostium).
  • Target lesion located within 3 mm of the origin of the LAD or LCX.
  • Lesion involving a bifurcation with a:
  • Side branch ≥ 2 mm in diameter, or
  • Side branch with diameter stenosis ≥ 50%, or
  • Side branch requiring protection guide wire, or
  • Side branch requiring pre-dilatation
  • Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE V, including:
  • Extreme angulation (≥ 90°) proximal to or within the target lesion
  • Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion
  • Moderate or heavy calcification proximal to or within the target lesion
  • Target lesion or target vessel involves a myocardial bridge.
  • Target vessel contains thrombus as indicated in the angiographic images.
  • Target vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE V would need to cross the stent to reach the target lesion.
  • Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.
  • Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
  • Residual %DS is < 40% (per visual estimation), ≤ 20% is strongly recommended.
  • TIMI Grade-3 flow (per visual estimation).
  • No angiographic complications (e.g. distal embolization, side branch closure).
  • No dissections National Heart, Lung, and Blood Institute (NHLBI) grade D-F.
  • No chest pain lasting > 5 minutes.
  • No ST depression or elevation lasting > 5 minutes.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abbott Vascular

    Santa Clara, California, 95054

Other trials in United States

About this study

Official title: A Clinical Evaluation of Absorb™ BVS, the Bioresorbable Vascular Scaffold, in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Chinese Population

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

Being tested
XIENCE V EECSS, Absorb BVS System
Keywords
Absorb™ BVS, Angioplasty, Bioabsorbable, BVS, Bioresorbable, Coronary Artery Disease, Coronary Artery Endothelial Responsiveness, Coronary artery restenosis, Coronary artery stenosis, Coronary scaffold, Coronary Stent, Drug eluting stents, Everolimus, Myocardial ischemia, Stent thrombosis, Stents
Medical subject headings
Coronary Artery Disease, Coronary Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia

What participants receive

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

  • XIENCE V EECSSDevice

    Subjects receiving XIENCE V

  • Absorb BVS SystemDevice

    Subjects receiving Absorb BVS System

Study groups in NCT01923740
Study groupRoleWhat they receive
Absorb BVS SystemExperimentalAbsorb BVS System: Subjects receiving Absorb BVS System
Receives: Device: Absorb BVS System
XIENCE V EECSSActive comparatorXIENCE V EECSS: Subjects receiving XIENCE V
Receives: Device: XIENCE V EECSS

What is being measured

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

  1. In-segment Late Loss (LL) - Per Subject Analysis

    In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

    Measured: 1 year

  2. In-segment Late Loss (LL) - Per Lesion Analysis

    In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

    Measured: 1 year

Secondary outcomes (127)

  1. Acute Device Success

    Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.

    Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

    Measured: < or = 1 day

  2. Number of Participants With Acute Procedural Success

    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success.

    Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

    Measured: At time of procedure up to 7 days in hospital

  3. Number of Death (Cardiac, Vascular, Non-cardiovascular)

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

  4. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    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: 0 to 37days

  5. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    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: 0 to 208 days

  6. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    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: 0 to 298 days

  7. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    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

  8. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    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 year

  9. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    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

  10. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    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

  11. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): 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

  12. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

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

  13. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 0 to 37 days

  14. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 0 to 208 days

  15. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 0 to 298 days

  16. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 1 year

  17. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 2 year

  18. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 3 years

  19. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 4 years

  20. Number of Participants With Myocardial Infarction

    MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

    Measured: 5 years

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

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

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 0 to 37 days

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 0 to 208 days

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 0 to 298 days

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 1 year

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 2 year

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 3 years

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 4 years

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

    • Ischemia-driven TLR (ID-TLR)
    • Not ischemia-driven TLR (NID-TLR)

    Measured: 5 years

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

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

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 0 to 37 days

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 0 to 208 days

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 0 to 298 days

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 1 year

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 2 year

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 3 years

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 4 years

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

    • Ischemia-driven TVR (ID-TVR)
    • Not ischemia-driven TVR (NID-TVR)

    Measured: 5 years

  39. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

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

  40. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 0 to 37days

  41. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 0 to 208 days

  42. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 0 to 298 Days

  43. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 1 year

  44. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 2 year

  45. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 3 years

  46. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 4 years

  47. Number of Participants With All Coronary Revascularization (PCI and CABG)

    All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

    Measured: 5 years

  48. Number of 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: Those MIs which are not Q-wave MI

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

  49. Number of 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: Those MIs which are not Q-wave MI

    Measured: 0 to 37 days

  50. Number of 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: Those MIs which are not Q-wave MI

    Measured: 0 to 208 days

  51. Number of 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: Those MIs which are not Q-wave MI

    Measured: 0 to 298 days

  52. Number of 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: Those MIs which are not Q-wave MI

    Measured: 1 year

  53. Number of 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: Those MIs which are not Q-wave MI

    Measured: 2 year

  54. Number of 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: Those MIs which are not Q-wave MI

    Measured: 3 years

  55. Number of 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: Those MIs which are not Q-wave MI

    Measured: 4 years

  56. Number of 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: Those MIs which are not Q-wave MI

    Measured: 5 years

  57. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

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

  58. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

    Measured: 0 to 37 days

  59. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

    Measured: 0 to 208 days

  60. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

    Measured: 0 to 298 days

  61. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

    Measured: 1 year

  62. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

    Measured: 2 year

  63. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

    Measured: 3 years

  64. Number of Cardiac Death/All MI

    Cardiac death (CD): 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.

    Measured: 4 years

  65. Number of Cardiac Death/All MI

    Cardiac death (CD): 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

    Measured: 5 years

  66. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

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

  67. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 0 to 37 days

  68. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 0 to 208 days

  69. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 0 to 298 days

  70. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 1 year

  71. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 2 year

  72. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 3 years

  73. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 4 years

  74. Number of Participants With All Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

    Measured: 5 years

  75. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

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

  76. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 0 to 37 days

  77. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 0 to 208 days

  78. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 0 to 298 days

  79. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 1 year

  80. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 2 year

  81. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 3 years

  82. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 4 years

  83. Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 5 years

  84. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

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

  85. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 0 to 37 days

  86. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 0 to 208 days

  87. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 0 to 298 days

  88. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 1 year

  89. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 2 year

  90. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 3 years

  91. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 4 years

  92. Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]

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

    Measured: 5 years

  93. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

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

  94. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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: 0 to 37 days

  95. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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: 0 to 208 days

  96. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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: 0 to 298 days

  97. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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

  98. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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 year

  99. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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

  100. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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

  101. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])

    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

  102. Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: < or = 1 day

  103. Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: >1 to 30 days

  104. Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 31 to 365 days

  105. Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 366 to 730 days

  106. Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 731 to 1095 days

  107. Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 366-1095 days

  108. Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 1096-1460 days

  109. Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 1461-1825 days

  110. Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 1096-1825 days

  111. Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 0-1825 days

  112. In-Device Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    Measured: 1 year

  113. In-Segment Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

    Measured: 1 year

  114. Proximal Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    Measured: 1 year

  115. Distal Minimum Lumen Diameter (MLD)

    Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

    Measured: 1 year

  116. In-Segment Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Measured: 1 year

  117. In-Device Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Measured: 1 year

  118. Proximal Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Measured: 1 year

  119. Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

    Measured: 1 year

  120. Distal Percent Diameter Stenosis (%DS)

    The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

    Measured: 1 year

  121. Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

    Measured: 1 year

  122. Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

    Measured: 1 year

  123. In-Segment Late Loss (LL)

    In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).

    Measured: 1 year

  124. Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)

    Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

    Measured: 1 year

  125. In-Device Late Loss (LL)

    In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).

    Measured: 1 year

  126. Proximal Late Loss (LL)

    Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup.

    Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.

    Measured: 1 year

  127. Distal Late Loss (LL)

    Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup.

    Distal is defined as within 5 mm of healthy tissue distal to the device placement.

    Measured: 1 year

Timeline

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

  1. First posted16 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMay 2015
  4. Study completion7 Mar 2019

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01923740
Sponsor's protocol ID
12-397
Acronym
ABSORB CHINA
Status last verified
Aug 2019
First submitted
25 Jul 2013
Last updated
4 Dec 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

  • 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

  • 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

  • Gao R, Yang Y, Han Y, Huo Y, Chen J, Yu B, Su X, Li L, Kuo HC, Ying SW, Cheong WF, Zhang Y, Su X, Xu B, Popma JJ, Stone GW; ABSORB China Investigators. Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial. J Am Coll Cardiol. 2015 Dec 1;66(21):2298-2309. doi: 10.1016/j.jacc.2015.09.054. Epub 2015 Oct 12.

    PubMed 26471805

Questions about this trial

What is this clinical trial studying?

A study testing XIENCE V EECSS and Absorb BVS System in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Abbott Medical Devices at 1 site in United States.

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 7 inclusion and 64 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 4 Dec 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 United States. 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 14 Feb 2018). 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?

In-segment Late Loss (LL) - Per Subject Analysis (time frame: 1 year). 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 NCT01923740, which also lists 4 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 4 Dec 2019.

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