Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- in-segment late loss
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).
Detailed Description
A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis. We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.
Investigators
Chang-Hwan Yoon
Assistant professor
Seoul National University Bundang Hospital
Eligibility Criteria
Inclusion Criteria
- •De novo lesion
- •2.5mm =\< Reference diameter =\< 4mm
- •Lesion length =\< 28mm
- •Type A, B1/B2 lesion
Exclusion Criteria
- •ST-segment elevation MI
- •Reference diameter \< 2.5mm or \> 4mm
- •Bifurcation lesion
- •Type C lesion
- •history of AMI or stroke within 1 year F. chronic renal disease (Cr \> 2mg/dL)
Outcomes
Primary Outcomes
in-segment late loss
Time Frame: 9 month
angiographic in-segment late loss measure by QCA program
Secondary Outcomes
- stent thrombosis(9 month)
- MACE(9 month)
- angiographic and procedure success(9 month)