NCT00440674终止4 期
The DECIDE Trial: Prospective, Multi-center, Randomized Study to Evaluate the CoStar Paclitaxel-Eluting Coronary Stent System Using a Direct Stenting Technique Compared to Conventional Stenting With Pre-dilatation Strategy
Conor Medsystems2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2007年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Adjudicated MACE at 30 days
研究概览
简要总结
The primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.
详细描述
Prospective, multi-center, randomized (1:1), open-label study to evaluate direct stenting compared to conventional stenting with pre-dilatation strategy in treatment of a single de novo Lesion of a single native coronary artery in patients undergoing elective percutaneous coronary intervention.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for percutaneous coronary intervention
- •Documented stable or unstable angina pectoris or with documented ischemia, or with documented silent ischemia
- •Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks
- •Acceptable candidate for coronary artery bypass graft surgery
- •Single target vessel / single target lesion to be treated
- •Target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent
- •Cumulative target lesion length per vessel is ≤ 25 mm
- •RVD of 2.5-3.5 mm
- •Target lesion diameter stenosis ≥ 50% and < 100%
- •Target vessel has not undergone prior revascularization within the preceding 6 months
排除标准
- •Known sensitivity to cobalt chromium, Paclitaxel or PLGA
- •Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q-wave, or a creatine kinase (CK) level of > 2x the laboratory upper limits of normal and elevated MB
- •The patient is in cardiogenic shock
- •Cerebrovascular Accident (CVA) within the past 6 months
- •Acute or chronic renal dysfunction (creatinine > 2.0 mg/dL or > 150 µmol/L)/
- •Contraindication to ASA or to Clopidogrel
- •Thrombocytopenia (platelet count <100,000/mm3)
- •Active gastrointestinal (GI) bleeding within the past three months
- •Any prior true anaphylactic reaction to contrast agents
- •Patient is currently taking Colchicine
- •Patient is currently, or has been treated with Paclitaxel (systemic) within12 months of the index procedure
- •Comorbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •Left main coronary artery disease (stenosis >50%), whether protected or unprotected.
- •Target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that requires intervention.
- •Target lesion is totally occluded Thrombolysis In MI (TIMI flow ≤1).
- •The target vessel has had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site.
- •Angiographic restenosis of any segment of the target vessel that has undergone prior PCI.
- •Angiographic evidence of atherosclerotic disease with >50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion is located in a branch vessel)
结局指标
主要结局
Adjudicated MACE at 30 days
时间窗: 30 days
次要结局
- Primary & second. device success, Lesion and Procedure success, Adjudicated MACE 8, 9, 12, 24 mos post-proc; Binary restenosis, MLD, Clin. driven TLR 8 mos post-proc; Clinic. driven TVR 8 mos post-proc; Overall TVR/TLR 8 mos post-proc; Stent thrombosis(8, 9, 12, 24 mos post-proc)
研究者
研究点 (2)
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