A German Multicenter, Randomized, Controlled, Open-Label Study of the Cypher Sirolimus-Eluting Stent in the Treatment of Diabetic Patients With De Novo Native Coronary Artery Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- angiographic in-segment 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 sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.
详细描述
This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions <= 42 mm in length and >=2.5mm and <=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month).
It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for 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
- •Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
- •Manifest diabetes mellitus, proven by fasting glucose (12 h) > 127 mg/dl or oral glucose challenge: >= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin;
- •Treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. If more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended;
- •Target vessel diameter at the lesion site is >= 2.5mm and <= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width);
- •Target lesion is <= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length);
- •Target lesion diameter stenosis is > 50% and <100% (visual estimate);
排除标准
- 未提供
研究组 & 干预措施
2
uncoated Bx VELOCITY balloon-expandable stent
干预措施: uncoated Bx VELOCITY balloon-expandable stent (Device)
1
CYPHER sirolimus-eluting stent
干预措施: CYPHER sirolimus-eluting stent (Device)
结局指标
主要结局
angiographic in-segment late loss
时间窗: 8 months post-procedure
次要结局
- late loss(8 months post-procedure)
- angiographic binary restenosis(8 months post-procedure)
- target lesion revascularization (TLR)(8 months post-procedure)
- target vessel revascularization (TVR)(8 months post-procedure)
- target vessel failure (TVF)(8 months post-procedure)
- procedure success(8 months post-procedure)
- lesion success rate(0)
- resource use(1 year post-procedure)
- productivity loss(1 year post-procedure)
- Major Adverse Cardiac Events (MACE)(30 days, and 8 and 12 months.)