Coronary Artery Disease | Comparison of Drug Eluting Balloon and Drug Eluting Stent
Coronary Artery Disease research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Coronary Artery Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Drug eluting balloon + Bare metal stentPCI using Sequent Please and then Coroflex Blue
Device:drug eluting stent (Zotarolimus-eluting stent)conventional PCI using Endeavor Integrity
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DEB-BMSDrug eluting balloon + Bare metal stent
Drug eluting stentconventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)
Start Date: April 2011
Completed Date: February 2015
Phase: Phase 2
Primary Outcome: in-segment late loss
Secondary Outcome: stent thrombosis
Study sponsors, principal investigator, and references
Principal Investigator: In-Ho Chae, MD
Lead Sponsor: Seoul National University Bundang Hospital