Ischemic Heart DiseaseNCT02513719
XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)
An observational study of Ischemic Heart Disease and Angina Pectoris, run by Abbott Medical Devices at 33 sites in Japan.
Trial summary
The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease
- What is being tested?
- XIENCE PRIME SV Everolimus Eluting Coronary Stent
- Type of treatment
- Medical device
- How many people
- 312 participants
- Where
- 33 sitesJapan
- Study dates
- 13 May 2013to Sep 2019
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General patient population with ischemic heart disease in Japan who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be included in the study.
- Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.
- If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
- Patients who are treated (stent delivery system inserted into the body) by XIENCE PRIME SV will be registered (including provisional stenting for side branch treatment but excluding bail-out only use).
- The observations will be compiled on a per-patient basis even if multiple stents are implanted during the index procedure.
- A patient whose side-branch is treated by XIENCE PRIME SV can be registered. In such a case, main vessel should be treated by XIENCE PRIME.
- A patient who are treated by other drug eluting stent (DES) for planned stent and XIENCE PRIME SV for bail-out purpose cannot be registered.
- Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.
- A patient who is treated, but failed to be implanted by XIENCE PRIME SV and finally treated by other devices only (No XIENCE PRIME SV are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the PRIME stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE PRIME SV stent is not required.
- A patient may have another lesion(s) that may be treated by larger diameter stent(s). In such a case, treatment by XIENCE PRIME is preferable. Lesion(s) treated by other than XIENCE PRIME is not considered as the target lesion.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Kimitsu Chuo Hospital
Chiba, 292-8535
Kokura Memorial Hospital
Fukuoka, 802-8555
Fukuoka Wajiro Hospital
Fukuoka, 811-0213
Hoshi general hospital
Fukushima, 963-8501
Tsuchiya General Hospital
Hiroshima, 730-0811
Hyogo Prefectural Amagasaki Hospital
Hyōgo, 660-0828
Tsukuba Medical Center Hospital
Ibaraki, 305-8558
Ishikawa Prefectual Central Hospital
Ishikawa, 920-8530
Shonan Kamakura General Hospital
Kanagawa, 247-8533
Tokai University Hospital
Kanagawa, 259-1193
Kumamoto Chuo Hospital
Kumamoto, 862-0965
Kyoto University Hospital
Kyoto, 606-8507
Miyazaki City-Gun Ishikai Hospital
Miyazaki, 880-0834
Kansai Rosai Hospital
Nagoya, 466-8650
Nagoya Daini Red Cross Hospital
Nagoya, 660-8511
Heart disease center Sakakibara hospital
Okayama, 700-0804
Kurashiki Central Hospital
Okayama, 710-8602
Sakurabashi Watanabe Hospital
Osaka, 530-0001
Osaka police hospital
Osaka, 543-0035
Osaka University Hospital
Osaka, 565-0871
Tokorozawa Heart Center
Saitama, 359-1142
Tokeidai memorial hospital
Sapporo, 060-0031
JCHO Hokkaido Hospital
Sapporo, 062-8618
Hokkaido Ohno hospital
Sapporo, 063-0034
Sendai Kousei Hospital
Sendai, 980-0873
Okamura memorial hospital
Shizuoka, 411-0904
Tokushima Red Cross Hospital
Tokushima, 773-8502
Mitsui Memorial Hospital
Tokyo, 101-8643
Toranomon hospital
Tokyo, 105-8470
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
Teikyo University Hospoital
Tokyo, 173-8606
Showa University Fujigaoka hospital
Yokohama, 227-8501
Saiseikai Yokohama City Tobu Hospital
Yokohama, 230-8765
About this study
Official title: XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance
The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.
Read the detailed description
Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
- Being tested
- XIENCE PRIME SV Everolimus Eluting Coronary Stent
- Keywords
- drug eluting stent, stent, real world
- Medical subject headings
- Myocardial Ischemia, Angina Pectoris, Coronary Artery Disease, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE PRIME SV Everolimus Eluting Coronary StentDevice
Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
| Study group | Role | What they receive |
|---|---|---|
| XIENCE PRIME SV Everolimus Eluting Coronary Stent | Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent Receives: Device: XIENCE PRIME SV Everolimus Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stent Thrombosis: Acute
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timing:
Acute stent thrombosis: 0 to 24 hours after stent implantation
Measured: 0-24 hours post stent implantation
Number of Participants With Stent Thrombosis: Subacute
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Subacute stent thrombosis : >24 hours to 30 days after stent implantation
Measured: >24 hours to 30 days post stent implantation
Number of Participants With Stent Thrombosis: Late
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Late stent thrombosis : >30 days to 1 year after stent implantation
Measured: 30 days to 1 year post stent implantation
Secondary outcomes (94)
Number of Participants With Stent Thrombosis: Very Late
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Very late stent thrombosis : >1 year after stent implantation.
Measured: >1 year post stent implantation
Percent Diameter Stenosis (%DS)
The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Measured: Pre-procedure
Percent Diameter Stenosis (%DS)
The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Measured: post procedure (on day 0)
Percent Diameter Stenosis (%DS)
The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Measured: 8 months
Success Rate: Percentage of Devices With Implant Success
The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25mm.
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: < or = 1 day
Success Rate: Percentage of Lesions 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 (less than or equal to 7 days).
Measured: < or = 1 day
Success Rate: XIENCE PRIME Implant Success by Patient
The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25 mm.
Implant success is assessed as per physicians decision, but means that the stent could be implanted at the intended location.
Measured: < or = 1 day
Number of Death
Death includes cardiac death, non-cardiac death and non-coronary death.
Measured: 0 to 8 months
Number of Death
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: 0 to 1 year
Number of Death
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: 0 to 2 years
Number of Death
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: 0-3 years
Number of Death
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: 0-4 years
Number of Death
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: 0-５ years
Number of Participants With Myocardial Infarction
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: 0 to 8 months
Number of Participants With Myocardial Infarction
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: 0 to 1 year
Number of Participants With Myocardial Infarction
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: 0 to 2 years
Number of Participants With Myocardial Infarction
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: 0-3 years
Number of Participants With Myocardial Infarction
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: 0-4 years
Number of Participants With Myocardial Infarction
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: 0-5 years
Number of Participants With Target Lesion Revascularization
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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR
Measured: 0 to 8 months
Number of Participants With Target Lesion Revascularization
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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR
Measured: 0 to 1 year
Number of Participants With Target Lesion Revascularization
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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR
Measured: 0 to 2 years
Number of Participants With Target Lesion Revascularization
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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR
Measured: 0-3 years
Number of Participants With Target Lesion Revascularization
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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR
Measured: 0-4 years
Number of Participants With Target Lesion Revascularization
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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR
Measured: 0-5 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)
Measured: 0 to 8 months
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)
Measured: 0 to 1 year
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
The number of patient with Ischemia-driven Target vessel revascularization (TLR or TVR, non-TLR)
Measured: 0 to 2 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)
Measured: 0-3 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)
Measured: 0-4 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)
Measured: 0-5 years
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: 0 to 8 months
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: 0 to 1 year
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: 0 to 2 years
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: 0 to 3 years
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: 0 to 4 years
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: 0 to 5 years
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: 0 to 8 months
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: 0 to 1 year
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: 0 to 2 years
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: 0 to 3 years
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: 0 to 4 years
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: 0 to 5 years
Number of Participants With Hemorrhage
Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.
Severe or life-threatening:
Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention
Moderate:
Bleeding that requires blood transfusion but does not result in hemodynamic compromise
Mild:
Bleeding that does not meet criteria for either moderate or severe bleeding
Measured: 0 to 8 months
Number of Participants With Hemorrhage
Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.
Severe or life-threatening:
Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention
Moderate:
Bleeding that requires blood transfusion but does not result in hemodynamic compromise
Mild:
Bleeding that does not meet criteria for either moderate or severe bleeding
Measured: 0 to 1 year
Number of Participants With Hemorrhage
Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.
Severe or life-threatening:
Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention
Moderate:
Bleeding that requires blood transfusion but does not result in hemodynamic compromise
Mild:
Bleeding that does not meet criteria for either moderate or severe bleeding
Measured: 0 to 2 years
Number of Participants With Hemorrhage
Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.
Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.
Measured: 0 to 3 years
Number of Participants With Hemorrhage
Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.
Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.
Measured: 0 to 4 years
Number of Participants With Hemorrhage
Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.
Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding.
Measured: 0 to 5 years
Number of Participants With Target Lesion Failure
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 8 months
Number of Participants With Target Lesion Failure
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 1 year
Number of Participants With Target Lesion Failure
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 2 years
Number of Participants With Target Lesion Failure
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 3 years
Number of Participants With Target Lesion Failure
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 4 years
Number of Participants With Target Lesion Failure
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 0 to 5 years
Number of Participants With All Death/All MI/All Revascularization
Measured: 0 to 8 months
Number of Participants With All Death/All MI/All Revascularization
Measured: 0 to 1 year
Number of Participants With All Death/All MI/All Revascularization
Measured: 0 to 2 years
Number of Participants With All Death/All MI/All Revascularization
Measured: 0 to 3 years
Number of Participants With All Death/All MI/All Revascularization
Measured: 0 to 4 years
Number of Participants With All Death/All MI/All Revascularization
Measured: 0 to 5 years
Number of Participants With Target Vessel Failure
Target vessel failure includes cardiac death, MI, ischemia driven TLR, ischemia driven TVR, non TLR and ischemia driven TVR (TLR or TVR, nonTLR).
Measured: 0 to 8 months
Number of Participants With Target Vessel Failure
Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).
Measured: 0 to 1 year
Number of Participants With Target Vessel Failure
Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).
Measured: 0 to 2 years
Number of Participants With Target Vessel Failure
Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).
Measured: 0 to 3 years
Number of Participants With Target Vessel Failure
Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).
Measured: 0 to 4 years
Number of Participants With Target Vessel Failure
Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).
Measured: 0 to 5 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Clinically indicated target lesion revascularization (CI-TLR).
Measured: 0 to 8 months
Number of Participants With Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).
Measured: 0 to 1 year
Number of Participants With Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).
Measured: 0 to 2 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).
Measured: 0 to 3 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).
Measured: 0 to 4 years
Number of Participants With Major Adverse Cardiac Events (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).
Measured: 0 to 5 years
Number of Participants With Death or 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: 0 to 8 months
Number of Participants With Death or 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: 0 to 1 year
Number of Participants With Death or 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: 0 to 2 years
Number of Participants With Death or 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: 0 to 3 years
Number of Participants With Death or 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: 0 to 4 years
Number of Participants With Death or 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: 0 to 5 years
Number of Participants With Cardiac Death or MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
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: 0 to 8 months
Number of Participants With Cardiac Death or MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) 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: 0 to 1 year
Number of Participants With Cardiac Death or MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
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: 0 to 2 years
Number of Participants With Cardiac Death or MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
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: 0 to 3 years
Number of Participants With Cardiac Death or MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
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: 0 to 4 years
Number of Participants With Cardiac Death or MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
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: 0 to 5 years
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Measured: 0 to 8 months
Number of Participants With Cardiac Death or Target Vessel-MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Measured: 0 to 1 year
Number of Participants With Cardiac Death or Target Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Measured: 0 to 2 years
Number of Participants With Cardiac Death or Target Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Measured: 0 to 3 years
Number of Participants With Cardiac Death or Target Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Measured: 0 to 4 years
Number of Participants With Cardiac Death or Target Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Measured: 0 to 5 years
Acute Gain: In-stent,In-segment
The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD).
Measured: Pre procedure to post procedure (on day 0)
Late Loss(LL): In-stent,In-segment,Proximal, and Distal
Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].
Measured: 8 months
Net Gain: In-stent, In-segment
Difference between acute gain and late loss.
Measured: Post-Procedure (on day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start13 May 2013
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Kozuma, MD, Study chair, Teikyo University Hospital, Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513719
- Sponsor's protocol ID
- 12-303
- Status last verified
- Apr 2021
- First submitted
- 17 Jul 2015
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT02513719
- Acronym / sponsor ID
- 12-303
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
- Keywords
- drug eluting stent, stent, real world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 13 May 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.
Detailed description
Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE PRIME SV Everolimus Eluting Coronary Stent | – | Device: XIENCE PRIME SV Everolimus Eluting Coronary StentPatients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General patient population with ischemic heart disease in Japan who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE PRIME SV Everolimus Eluting Coronary StentPatients receiving XIENCE PRIME SV Everolimus Eluting Stent | Device | XIENCE PRIME SV Everolimus Eluting Coronary Stent |
Primary outcome
Number of Participants With Stent Thrombosis: Acute
Time frame: 0-24 hours post stent implantation
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timing: Acute stent thrombosis: 0 to 24 hours after stent implantation
Number of Participants With Stent Thrombosis: Subacute
Time frame: >24 hours to 30 days post stent implantation
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Subacute stent thrombosis : >24 hours to 30 days after stent implantation
Number of Participants With Stent Thrombosis: Late
Time frame: 30 days to 1 year post stent implantation
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Late stent thrombosis : >30 days to 1 year after stent implantation
94 secondary outcomes
Number of Participants With Stent Thrombosis: Very Late
Time frame: >1 year post stent implantation
Percent Diameter Stenosis (%DS)
Time frame: Pre-procedure
Percent Diameter Stenosis (%DS)
Time frame: post procedure (on day 0)
Percent Diameter Stenosis (%DS)
Time frame: 8 months
Success Rate: Percentage of Devices With Implant Success
Time frame: < or = 1 day
Success Rate: Percentage of Lesions With Procedural Success
Time frame: < or = 1 day
Success Rate: XIENCE PRIME Implant Success by Patient
Time frame: < or = 1 day
Number of Death
Time frame: 0 to 8 months
Number of Death
Time frame: 0 to 1 year
Number of Death
Time frame: 0 to 2 years
Number of Death
Time frame: 0-3 years
Number of Death
Time frame: 0-4 years
Number of Death
Time frame: 0-５ years
Number of Participants With Myocardial Infarction
Time frame: 0 to 8 months
Number of Participants With Myocardial Infarction
Time frame: 0 to 1 year
Number of Participants With Myocardial Infarction
Time frame: 0 to 2 years
Number of Participants With Myocardial Infarction
Time frame: 0-3 years
Number of Participants With Myocardial Infarction
Time frame: 0-4 years
Number of Participants With Myocardial Infarction
Time frame: 0-5 years
Number of Participants With Target Lesion Revascularization
Time frame: 0 to 8 months
Number of Participants With Target Lesion Revascularization
Time frame: 0 to 1 year
Number of Participants With Target Lesion Revascularization
Time frame: 0 to 2 years
Number of Participants With Target Lesion Revascularization
Time frame: 0-3 years
Number of Participants With Target Lesion Revascularization
Time frame: 0-4 years
Number of Participants With Target Lesion Revascularization
Time frame: 0-5 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Time frame: 0 to 8 months
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Time frame: 0 to 1 year
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Time frame: 0 to 2 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Time frame: 0-3 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Time frame: 0-4 years
Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)
Time frame: 0-5 years
Number of Participants With Non-target Vessel Revascularization (Non-TVR)
Time frame: 0 to 8 months
Number of Participants With Non-target Vessel Revascularization (Non-TVR)
Time frame: 0 to 1 year
Number of Participants With Non-target Vessel Revascularization (Non-TVR)
Time frame: 0 to 2 years
Number of Participants With Non-target Vessel Revascularization (Non-TVR)
Time frame: 0 to 3 years
Number of Participants With Non-target Vessel Revascularization (Non-TVR)
Time frame: 0 to 4 years
Number of Participants With Non-target Vessel Revascularization (Non-TVR)
Time frame: 0 to 5 years
Number of Participants With All Revascularization
Time frame: 0 to 8 months
Number of Participants With All Revascularization
Time frame: 0 to 1 year
Number of Participants With All Revascularization
Time frame: 0 to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Kozuma, MD study chair
Teikyo University Hospital, Tokyo
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Angina Pectoris, run by Abbott Medical Devices at 33 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Japan. 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 22 Jul 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?
Number of Participants With Stent Thrombosis: Acute (time frame: 0-24 hours post stent implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.