Comparison of Drug Eluting Balloon and Drug Eluting Stent

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.

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)