NCT00699543Unknown3 期
The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention: Comparison or Efficacy Between COroflex PLEASe ANd TaxusTM Stent
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 915
- 主要终点
- Clinically driven Target vessel Revascularization (TVR)
研究概览
简要总结
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
- Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
- Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
- Stent thrombosis
B. Angiographic efficacy end points
- in-stent binary restenosis by QCA
- in-stent and in-lesion late loss by QCA
- in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Subject must be at least 18 years of age.
- •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.
- •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
- •Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.5 mm and ≤ 4.0 mm.
- •Target lesion(s) must be amenable for percutaneous coronary intervention
排除标准
- •General Exclusion Criteria
- •The patient has a known hypersensitivity or contraindication to any of the following medications:
- •Both Clopidogrel and Ticlopidine
- •Paclitaxel
- •Stainless steel
- •Contrast media(*) (*)Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
- •Systemic (intravenous) Paclitaxel use within 12 months.
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- •History of bleeding diathesis or known coagulopathy (including heparin- induced thrombocytopenia), or will refuse blood transfusions.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Patients with LVEF<25% or those with cardiogenic shock
- •Patients with acute ST elevation myocardial infarction who requires primary PCI
- •Patients with acute ST elevation myocardial infarction within 48hrs
- •Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
- •Angiographic Exclusion Criteria
- •Patients with significant left main stem stenosis which requires revascularization therapy
- •Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
- •Target lesions with bifurcating disease which require side branch stenting
研究组 & 干预措施
C
Experimental
Coroflex Please stent implantation
干预措施: Coroflex Please stent implantation (Device)
T
Active Comparator
Taxus stent implantation
干预措施: Taxus stent implantation (Device)
结局指标
主要结局
Clinically driven Target vessel Revascularization (TVR)
时间窗: 9 months.
次要结局
- 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)
- 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)
- Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)(1, 4, 9, 12 months and 2, 3years)
- In-stent binary restenosis by QCA(9 months)
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