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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01268371
First received: December 29, 2010
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Device: Promus Element, Boston Scientific Corporation
Device: Nobori, Terumo Corporation (Japan)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Death (all-cause and cardiac) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q wave and non-Q wave) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia- and clinically-driven) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia- and clinically-driven) [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment late loss at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • In-stent and in-segment restenosis at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up [ Time Frame: 1 year after index procedure ] [ Designated as safety issue: No ]
  • The incidence of Procedural success [ Time Frame: index procedure (day 0) ] [ Designated as safety issue: No ]
  • The number of participants with death and myocardial infarction [ Time Frame: 1 to 2 years after index procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1462
Study Start Date: December 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Promus Element
Everolimus-eluting stent
Device: Promus Element, Boston Scientific Corporation
Everolimus-eluting stent
Other Name: Everolimus-eluting stent
Active Comparator: Nobori
Biolimus-eluting stent with biodegradable polymer
Device: Nobori, Terumo Corporation (Japan)
Biolimus-eluting stent with biodegradable polymer
Other Name: Biolimus-eluting stent with biodegradable polymer

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268371

Locations
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
Konyang University Hospital
Daejon, Korea, Republic of
Chungnam National 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
Kyunghee University Medical Center
Seoul, Korea, Republic of
Yonsei University Gangnam Severance Hospital
Seoul, Korea, Republic of
Hallym University Hankang Sacred Heart Hospital
Seoul, Korea, Republic of
The Catholic University of Korea Seoul ST. Mary`s Hospital
Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of
St. Carollo Hospital
Suncheon, Korea, Republic of
Catholic University ST. Vincent`s Hospital
Suwon, Korea, Republic of
Ajou University Medical Center
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, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Seung-Jea Tahk, MD, PhD Department of Cardiology, Ajou University School of Medicine
  More Information

No publications provided

Responsible Party: Seung-Jea Tahk, Dr., Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01268371     History of Changes
Other Study ID Numbers: BESS
Study First Received: December 29, 2010
Last Updated: February 11, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ajou University School of Medicine:
Coronary artery disease
Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014