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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01268371
Other study ID # BESS
Secondary ID
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


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
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