Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

Ajou University School of Medicine26 sites in 1 country1,462 target enrollmentDecember 2010

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Ajou University School of Medicine
Enrollment: 1462
Locations: 26
Primary Endpoint: The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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®)

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

July 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ajou University School of Medicine

Responsible Party

Principal Investigator

Seung-Jea Tahk

Dr.

Ajou University School of Medicine

Eligibility Criteria

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)