Objectives : To evaluate the clinical efficacy, angiographic outcomes, and safety of the new paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the treatment of coronary stenosis. Study Design : Prospective, open label, 2: 1 randomized multi-center trial. Patients will be randomized according to the type of drug eluting stent ( CoroflexTM Please vs. TaxusTM). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length \> 28mm) Patient Enrollment :915 patients enrolled at 13 centers in Korea. Patient Follow-Up :Clinical follow-up will occur at 1, 4, 9, 12 months and 2, 3years after intervention. Investigator or designee may conduct follow-up as telephone contacts or office visits. Primary Endpoint :Clinically driven Target vessel Revascularization (TVR) at 9 months. Secondary Endpoints :A. Clinical safety and efficacy end points 1. Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR) 2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR) 3. Stent thrombosis B. Angiographic efficacy end points 1. in-stent binary restenosis by QCA 2. in-stent and in-lesion late loss by QCA 3. in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
915
Use Coroflex Please stent in the treatment of coronary stenosis
Use Taxus stent in the treatment of coronary stenosis
Clinically driven Target vessel Revascularization (TVR)
Time frame: 9 months.
Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
Time frame: 1, 4, 9, 12 months and 2, 3years
Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
Time frame: 1, 4, 9, 12 months and 2, 3years
Stent thrombosis
Time frame: 1, 4, 9, 12 months and 2, 3years
In-stent binary restenosis by QCA
Time frame: 9 months
In-stent and in-lesion late loss by QCA
Time frame: 9 months
In-stent and in-lesion MLD and percentage diameter stenosis by QCA
Time frame: Immediately after the index procedure and at 9 months
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