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

This study is currently recruiting participants.
Verified April 2013 by Ajou University School of Medicine
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: April 13, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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

Contacts
Contact: Seung-Jea Tahk, MD, PhD +82 31 219 5712 sjtahk@ajou.ac.kr
Contact: Hyoung-Mo Yang, MD +82 31 219 5719 yhhm20@hanmail.net

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of
Principal Investigator: Woo-Jung Park, MD            
Sejong Hospital Recruiting
Bucheon, Korea, Republic of
Principal Investigator: Chul-Woong Yoo, MD            
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Korea, Republic of
Principal Investigator: Nae-Hui Lee, MD            
Cheju Halla General Hospital Recruiting
Cheju, Korea, Republic of
Principal Investigator: Seung-Ho Kang, MD            
Soon Chun Hyang University Hospital Cheonan Recruiting
Cheonan, Korea, Republic of
Principal Investigator: Seung-Jin Lee, MD            
Kangwon National University Hospital Recruiting
Chuncheon, Korea, Republic of
Principal Investigator: Bong-Ki Lee, MD            
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Principal Investigator: Ki-Sik Kim, MD            
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of
Principal Investigator: Seung-Ho Hur, MD            
Konyang University Hospital Recruiting
Daejon, Korea, Republic of
Principal Investigator: Jang-HO Bae, MD            
Chungnam National University Hospital Recruiting
Daejon, Korea, Republic of
Principal Investigator: Jae-Hwan Lee, MD            
Gangneung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Principal Investigator: Sang-Yong Yoo, MD            
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Principal Investigator: Myung-Ho Jeong, MD            
Inje University ilsan Paik Hospital Recruiting
Ilsan, Korea, Republic of
Principal Investigator: Sung-Yoon Lee, MD            
Gachon University Gil Hospital Recruiting
Incheon, Korea, Republic of
Principal Investigator: Tae-Hoon Ahn, MD            
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Principal Investigator: Kwang-Soo Cha, MD            
Kyunghee University Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Myeung-Kon Kim, MD            
Yonsei University Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Hyuck-Moon Kwon, MD            
Hallym University Hankang Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Yong-Jin Choi, MD            
The Catholic University of Korea Seoul ST. Mary`s Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Ki-Bai Seung, MD            
Hallym University Kangdong Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Kyoo-Rok Han, MD            
St. Carollo Hospital Recruiting
Suncheon, Korea, Republic of
Principal Investigator: Jang-Hyun Jo, MD            
Catholic University ST. Vincent`s Hospital Recruiting
Suwon, Korea, Republic of
Principal Investigator: Ki-Dong Yoo, MD            
Ajou University Medical Center Recruiting
Suwon, Korea, Republic of
Principal Investigator: Seung-Jea Tahk, MD, PhD            
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Principal Investigator: Sang-Gon Lee, MD            
Yonsei University Wonju College of Medicine Wonju Christion Hospital Recruiting
Wonju, Korea, Republic of
Principal Investigator: Jung-Han Yoon, MD            
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Principal Investigator: Joon-Hong Kim, MD            
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: April 13, 2013
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 May 23, 2013