Coronary Artery Disease
Conditions
Brief summary
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
Interventions
DEVICECoroflex Please stent implantation
Use Coroflex Please stent in the treatment of coronary stenosis
DEVICETaxus stent implantation
Use Taxus stent in the treatment of coronary stenosis
Sponsors
B. Braun Melsungen AG
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the CoroflexTM Please stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. 3. Subject must have coronary artery stenosis (\>50% by visual estimate) with evidence of myocardial ischemia (e.g., stable, unstable angina, myocardial infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia.) or Subject must have significant coronary artery stenosis (\>70% by visual estimate) * Angiographic Inclusion Criteria 1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.5 mm and ≤ 4.0 mm. 2. Target lesion(s) must be amenable for percutaneous coronary intervention
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically driven Target vessel Revascularization (TVR) | 9 months. |
Secondary
| Measure | Time frame |
|---|---|
| Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR) | 1, 4, 9, 12 months and 2, 3years |
| Stent thrombosis | 1, 4, 9, 12 months and 2, 3years |
| Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR) | 1, 4, 9, 12 months and 2, 3years |
| In-stent and in-lesion late loss by QCA | 9 months |
| In-stent and in-lesion MLD and percentage diameter stenosis by QCA | Immediately after the index procedure and at 9 months |
| In-stent binary restenosis by QCA | 9 months |
Outcome results
None listed