A Randomized Study With the CYPHER SELECT™ Sirolimus-Eluting Balloon-Expandable Coronary Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Angiographic in-stent late loss
研究概览
简要总结
The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.
详细描述
This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;
- •Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion;
- •Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
- •Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent;
- •Target lesion stenosis is > 50% and < 100% (visual estimate).
排除标准
- •A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
- •Unprotected left main coronary disease with more than 50% stenosis;
- •Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
- •Have an ostial target lesion;
- •Angiographic evidence of thrombus within target lesion;
- •Calcified lesions which cannot be successfully predilated;
- •Ejection fraction less than 30%;
- •Totally occluded vessel (TIMI 0 level);
- •Direct Stenting;
结局指标
主要结局
Angiographic in-stent late loss
时间窗: 6 months
次要结局
- In-stent mean percent diameter stenosis(anytime post-procedure)
- In-target vessel segment MLD(6 months)
- In-stent MLD(6 months)
- Target Lesion Revascularization (TLR)(6 months)
- Target Vessel Revascularization (TVR)(6 months)
- Major Adverse Cardiac Events (MACE)(30 days, 6 and 12 months)
- In-stent volume of restenosis determined by IVUS(6 months)