E-Sirius Study: a European, Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- In-stent minimum lumen diameter (MLD).
研究概览
简要总结
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.
详细描述
This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.
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
- Double (Participant, Investigator)
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
- •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) OR patients with documented silent ischemia;
- •Treatment of a single de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
- •Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);
- •Target lesion is >=15mm and <=32mm in length (visual estimate);
- •Target lesion stenosis is >50% and <100% (visual estimate);
排除标准
- •Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
- •Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
- •Unprotected left main coronary disease with >=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;
- •Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
- •Documented left ventricular ejection fraction <=25%;
结局指标
主要结局
In-stent minimum lumen diameter (MLD).
时间窗: 8 months.
次要结局
- Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR.(1, 6, 9, and 12 months; 2, 3, 4, 5, 6, 7 and 8 years post procedure.)
- Angiographic binary restenosis (>=50% diameter stenosis).(8 months.)
- In-lesion MLD.(8 months.)
- Target lesion revascularization.(9 months.)
- Target vessel revascularization.(9 months.)
- Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.(9 months.)
- Device success (final residual diameter stenosis of < 50%).(any time post-procedure.)