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

Coronary Artery Disease Clinical Trial

— BESS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01268371
• Other study ID #: BESS
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 29, 2010
• Last updated: February 11, 2014
• Start date: December 2010
• Est. completion date: July 2015

Study information

• Verified date: February 2014
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1462
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Promus Element, Boston Scientific Corporation
Everolimus-eluting stent
• Nobori, Terumo Corporation (Japan)
Biolimus-eluting stent with biodegradable polymer

Locations

Country	Name	City	State
Korea, Republic of	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	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inje University ilsan Paik Hospital	Ilsan
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Hallym University Hankang Sacred Heart Hospital	Seoul
Korea, Republic of	Hallym University Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea Seoul ST. Mary`s Hospital	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul
Korea, Republic of	St. Carollo Hospital	Suncheon
Korea, Republic of	Ajou University Medical Center	Suwon
Korea, Republic of	Catholic University ST. Vincent`s Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Yonsei University Wonju College of Medicine Wonju Christion Hospital	Wonju
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Death (all-cause and cardiac)		1 to 2 years after index procedure	Yes
Secondary	Myocardial infarction (Q wave and non-Q wave)		1 to 2 years after index procedure	Yes
Secondary	Target vessel revascularization (ischemia- and clinically-driven)		1 to 2 years after index procedure	No
Secondary	Target lesion revascularization (ischemia- and clinically-driven)		1 to 2 years after index procedure	No
Secondary	Stent thrombosis		1 to 2 years after index procedure	Yes
Secondary	In-stent and in-segment late loss at 1 year angiographic follow-up		1 year after index procedure	No
Secondary	In-stent and in-segment restenosis at 1 year angiographic follow-up		1 year after index procedure	No
Secondary	Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up		1 year after index procedure	No
Secondary	The incidence of Procedural success		index procedure (day 0)	No
Secondary	The number of participants with death and myocardial infarction		1 to 2 years after index procedure	Yes