The purpose of this study is to assess whether the outcome of treatment with CoroflexTM Please stent is not inferior to the outcome of treatment with TAXUS stent.
To establish the effectiveness and the safety of coronary stenting with the newly developed paclitaxel-eluting balloon expandable stent (CoroflexTM Please stent, B. Bran, Melsungen, Germany), compared to the conventional paclitaxel-eluting balloon expandable stent (TAXUS stent, Boston scientific) in the treatment of coronary stenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
highly flexible CoroflexTM Please-Stent
Paclitaxel-eluting stent
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
In-segment late lumen loss by quantitative coronary angiographic measurements
Time frame: 9 months
All Death
Time frame: 12 months
Cardiac death
Time frame: 12 months
Myocardial infarction
Time frame: 12 month
Target vessel revascularization (all and ischemia-driven)
Time frame: 12 month
Target lesion revascularization (all and ischemia-driven)
Time frame: 12 months
Stent thrombosis (by ARC definition)
Time frame: 12 months
In-stent late loss at 9 month angiographic follow-up
Time frame: 12 months
Binary restenosis in both in-stent and in-segment
Time frame: 9 month
Angiographic pattern of restenosis
Time frame: 9 months
Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion
Time frame: during the hospital stay
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Hallym University Sacred Heart Hospital
Pyeongchon, South Korea
Asan Medical Center
Seoul, South Korea
Hangang Sacred Heart Hospital
Seoul, South Korea
Seoul Veterans Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea