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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Promus Element, Boston Scientific Corporation; Device: Nobori, Terumo Corporation (Japan)

• Study Type: Interventional
• Enrollment (Anticipated): 1462
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Bucheon, Korea, Republic of
    • Sejong Hospital
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Cheju, Korea, Republic of
    • Cheju Halla General Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Chuncheon, Korea, Republic of
    • KangWon National University Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Hospital
  • Daejon, Korea, Republic of
    • Chungnam National University Hospital
  • Daejon, Korea, Republic of
    • Konyang University Hospital
  • Gangneung, Korea, Republic of
    • Gangneung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seoul, 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
  • Suncheon, Korea, Republic of
    • St. Carollo Hospital
  • Suwon, Korea, Republic of
    • Ajou University Medical Center
  • Suwon, Korea, Republic of
    • Catholic University St. Vincent's Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Yonsei University Wonju College of Medicine Wonju Christion Hospital
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Promus Element; Everolimus-eluting stent	Device: Promus Element, Boston Scientific Corporation; Everolimus-eluting stent; Other Names: Everolimus-eluting stent
Active Comparator: Nobori; Biolimus-eluting stent with biodegradable polymer	Device: Nobori, Terumo Corporation (Japan); Biolimus-eluting stent with biodegradable polymer; Other Names: Biolimus-eluting stent with biodegradable polymer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Seung-Jea Tahk, MD, PhD, Department of Cardiology, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (Estimate): December 30, 2010

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Coronary artery disease; Stent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: BESS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No