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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- in-segment late loss
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
DEB-BMS
Drug eluting balloon + Bare metal stent
Intervention: Drug eluting balloon + Bare metal stent (Device)
Drug eluting stent
conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)
Intervention: drug eluting stent (Zotarolimus-eluting stent) (Device)
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)
Investigators
Chang-Hwan Yoon
Assistant professor
Seoul National University Bundang Hospital