Status:
TERMINATED
Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
Abbott Medical Devices
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the safety and efficacy of coronary stent implantation using Everolimus-Eluting Coronary Stent System (Abbott, Boston Scientific) is not inferior to c...
Detailed Description
The primary purpose of the BEST Study is to determine whether the safety and efficacy of coronary stent implantation using everolimus-eluting balloon expandable stents is not inferior to coronary arte...
Eligibility Criteria
Inclusion
- Age 18 years of older
- Angiographically confirmed multivessel CAD \[critical (\>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)\] and amenable to either PCI or CABG.
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- Geographically accessible and willing to come in for required study visits
- Signed informed consent.
Exclusion
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
- Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
- In-stent restenosis of a target vessel
- Prior CABG surgery
- Prior PCI with stent implantation within 1 year
- Two or more chronic total occlusions in major coronary territories
- Acute ST-elevation MI(Q-wave) within 72 hours prior to enrollment requiring revascularization
- Abnormal creatine kinase (CK \> 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization
- Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score \> 1
- Dementia with a Mini Mental Status Examination (MMSE) score of ≤ 20
- Extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
- Contraindication either CABG or PCI/DES because of a coexisting clinical condition
- Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
- Suspected pregnancy. A pregnancy test (urine or serum) will be administered prerandomization to all women not clearly menopausal
- Concurrent enrollment in another clinical trial
Key Trial Info
Start Date :
July 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2019
Estimated Enrollment :
888 Patients enrolled
Trial Details
Trial ID
NCT00997828
Start Date
July 28 2008
End Date
April 5 2019
Last Update
May 10 2019
Active Locations (27)
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1
Sir Run Run Shaw Hospital
Hangzhou, China
2
Zhongshan Hospital
Shanghai, China
3
National Heart Institue
Kuala Lumpur, Malaysia
4
Sarawak General Hospital
Kuching, Malaysia