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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Promus Element, Boston Scientific Corporation
Nobori, Terumo Corporation (Japan)
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Stent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • Sejong Hospital
  • Soon Chun Hyang University Hospital Bucheon
  • Cheju Halla General Hospital
  • Soon Chun Hyang University Hospital Cheonan
  • Kangwon National University Hospital
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Hospital
  • Chungnam National University Hospital
  • Konyang University Hospital
  • Gangneung Asan Hospital
  • Chonnam National University Hospital
  • Inje University ilsan Paik Hospital
  • Gachon University Gil Hospital
  • Pusan National University Hospital
  • Hallym University Hankang Sacred Heart Hospital
  • Hallym University Kangdong Sacred Heart Hospital
  • Kyunghee University Medical Center
  • The Catholic University of Korea Seoul ST. Mary's Hospital
  • Yonsei University Gangnam Severance Hospital
  • St. Carollo Hospital
  • Ajou University Medical Center
  • Catholic University ST. Vincent's Hospital
  • Ulsan University Hospital
  • Yonsei University Wonju College of Medicine Wonju Christion Hospital
  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Promus Element

Nobori

Arm Description

Everolimus-eluting stent

Biolimus-eluting stent with biodegradable polymer

Outcomes

Primary Outcome Measures

The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis

Secondary Outcome Measures

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

Full Information

First Posted
December 29, 2010
Last Updated
February 11, 2014
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01268371
Brief Title
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Acronym
BESS
Official Title
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Promus Element
Arm Type
Active Comparator
Arm Description
Everolimus-eluting stent
Arm Title
Nobori
Arm Type
Active Comparator
Arm Description
Biolimus-eluting stent with biodegradable polymer
Intervention Type
Device
Intervention Name(s)
Promus Element, Boston Scientific Corporation
Other Intervention Name(s)
Everolimus-eluting stent
Intervention Description
Everolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Nobori, Terumo Corporation (Japan)
Other Intervention Name(s)
Biolimus-eluting stent with biodegradable polymer
Intervention Description
Biolimus-eluting stent with biodegradable polymer
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Death (all-cause and cardiac)
Time Frame
1 to 2 years after index procedure
Title
Myocardial infarction (Q wave and non-Q wave)
Time Frame
1 to 2 years after index procedure
Title
Target vessel revascularization (ischemia- and clinically-driven)
Time Frame
1 to 2 years after index procedure
Title
Target lesion revascularization (ischemia- and clinically-driven)
Time Frame
1 to 2 years after index procedure
Title
Stent thrombosis
Time Frame
1 to 2 years after index procedure
Title
In-stent and in-segment late loss at 1 year angiographic follow-up
Time Frame
1 year after index procedure
Title
In-stent and in-segment restenosis at 1 year angiographic follow-up
Time Frame
1 year after index procedure
Title
Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up
Time Frame
1 year after index procedure
Title
The incidence of Procedural success
Time Frame
index procedure (day 0)
Title
The number of participants with death and myocardial infarction
Time Frame
1 to 2 years after index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jea Tahk, MD, PhD
Organizational Affiliation
Department of Cardiology, Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Sejong Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
Country
Korea, Republic of
Facility Name
Cheju Halla General Hospital
City
Cheju
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejon
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejon
Country
Korea, Republic of
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Inje University ilsan Paik Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Hallym University Hankang Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St. Carollo Hospital
City
Suncheon
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Suwon
Country
Korea, Republic of
Facility Name
Catholic University ST. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Yonsei University Wonju College of Medicine Wonju Christion Hospital
City
Wonju
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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