Coronary Artery Disease Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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