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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
PCI using Sequent Please and then Coroflex Blue
conventional PCI using Endeavor Integrity
Seoul National Universtiy Bundang Hospital
Seongnam, South Korea
in-segment late loss
angiographic in-segment late loss measure by QCA program
Time frame: 9 month
stent thrombosis
any stent thrombosis
Time frame: 9 month
angiographic and procedure success
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.
Time frame: 9 month
MACE
death, MI and TVF
Time frame: 9 month
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