Comparison of Drug Eluting Balloon and Drug Eluting Stent (DEBfirst)
|Coronary Artery Disease Stable Angina Unstable Angina NSTEMI||Device: Drug eluting balloon + Bare metal stent Device: drug eluting stent (Zotarolimus-eluting stent)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- in-segment late loss [ Time Frame: 9 month ]angiographic in-segment late loss measure by QCA program
- stent thrombosis [ Time Frame: 9 month ]any stent thrombosis
- angiographic and procedure success [ Time Frame: 9 month ]
Angiographic success denotes that residual diameter stenosis is less than 10% without complication such as coronarhy dissection or thrombosis.
Procedural success means that adequate DEB+BMS or DES delivery to the target lesion without geographic miss.
- MACE [ Time Frame: 9 month ]death, MI and TVF
|Study Start Date:||April 2011|
|Study Completion Date:||February 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Drug eluting balloon + Bare metal stent
Device: Drug eluting balloon + Bare metal stent
PCI using Sequent Please and then Coroflex Blue
Active Comparator: Drug eluting stent
conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)
Device: drug eluting stent (Zotarolimus-eluting stent)
conventional PCI using Endeavor Integrity
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539603
|Korea, Republic of|
|Seoul National Universtiy Bundang Hospital|
|Seongnam, Korea, Republic of, 463-707|
|Principal Investigator:||In-Ho Chae, MD||Seoul National University Bundang Hospital|