Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments promus element, boston scientific corporation, nobori, terumo corporation (japan)
Phase phase 4
Sponsor Ajou University School of Medicine
Start date December 2010
End date July 2015
Trial size 1462 participants
Trial identifier NCT01268371, BESS

Summary

To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Everolimus-eluting stent
promus element, boston scientific corporation Everolimus-eluting stent
Everolimus-eluting stent
(Active Comparator)
Biolimus-eluting stent with biodegradable polymer
nobori, terumo corporation (japan) Biolimus-eluting stent with biodegradable polymer
Biolimus-eluting stent with biodegradable polymer

Primary Outcomes

Measure
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

Measure
The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
time frame: 2 years after index procedure
Death (all-cause and cardiac)
time frame: 1 to 2 years after index procedure
Myocardial infarction (Q wave and non-Q wave)
time frame: 1 to 2 years after index procedure
Target vessel revascularization (ischemia- and clinically-driven)
time frame: 1 to 2 years after index procedure
Target lesion revascularization (ischemia- and clinically-driven)
time frame: 1 to 2 years after index procedure
Stent thrombosis
time frame: 1 to 2 years after index procedure
In-stent and in-segment late loss at 1 year angiographic follow-up
time frame: 1 year after index procedure
In-stent and in-segment restenosis at 1 year angiographic follow-up
time frame: 1 year after index procedure
Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up
time frame: 1 year after index procedure
The incidence of Procedural success
time frame: index procedure (day 0)
The number of participants with death and myocardial infarction
time frame: 1 to 2 years after index procedure

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Principal investigator Seung-Jea Tahk, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Ajou University School of Medicine.