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

Phase 4

• Conditions: Coronary Artery Disease

• Registration Number: NCT01268371
• Lead Sponsor: Ajou University School of Medicine

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®)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-30
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1462

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis	1 year after index procedure

Secondary Outcome Measures

Name	Time	Method
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 late loss at 1 year angiographic follow-up	1 year 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

Trial Locations

Locations (26)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Sejong Hospital; 🇰🇷 Bucheon, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

Cheju Halla General Hospital; 🇰🇷 Cheju, Korea, Republic of

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejon, Korea, Republic of

Konyang University Hospital; 🇰🇷 Daejon, Korea, Republic of

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