NCT01268371UnknownPhase 4
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Ajou University School of Medicine26 sites in 1 country1,462 target enrollmentStarted: December 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 1,462
- Locations
- 26
- Primary Endpoint
- The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
Study Overview
Brief Summary
To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Significant coronary artery stenosis (> 50% by visual estimate)
- •Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia
- •Patients eligible for intracoronary stenting
- •age ≥ 20 years old
Exclusion Criteria
- •ST segment elevation myocardial infarction (within 24 hours)
- •Low ejection fraction (< 25%)
- •Cardiogenic shock
- •History of bleeding diathesis or known coagulopathy
- •Limited life-expectancy (less than 1 year) due to combined serious disease
- •Contraindication to heparin, sirolimus, everolimus and biolimus
- •Contraindication to aspirin and clopidogrel
- •Pregnancy
Outcomes
Primary Outcomes
The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
Time Frame: 1 year after index procedure
Secondary Outcomes
- In-stent and in-segment late loss at 1 year angiographic follow-up(1 year after index procedure)
- The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis(2 years after index procedure)
- Death (all-cause and cardiac)(1 to 2 years after index procedure)
- Myocardial infarction (Q wave and non-Q wave)(1 to 2 years after index procedure)
- Target vessel revascularization (ischemia- and clinically-driven)(1 to 2 years after index procedure)
- Target lesion revascularization (ischemia- and clinically-driven)(1 to 2 years after index procedure)
- Stent thrombosis(1 to 2 years after index procedure)
- In-stent and in-segment restenosis at 1 year angiographic follow-up(1 year after index procedure)
- Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up(1 year after index procedure)
- The incidence of Procedural success(index procedure (day 0))
- The number of participants with death and myocardial infarction(1 to 2 years after index procedure)
Investigators
Seung-Jea Tahk
Dr.
Ajou University School of Medicine
Study Sites (26)
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