Comparison of Drug Eluting Balloon and Drug Eluting Stent (DEBfirst)
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|ClinicalTrials.gov Identifier: NCT01539603|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : June 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Stable Angina Unstable Angina NSTEMI||Device: Drug eluting balloon + Bare metal stent Device: drug eluting stent (Zotarolimus-eluting stent)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||February 2015|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|