NCT01093391已完成3 期
A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)
Scitech Produtos Medicos Ltda8 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- Lumen Loss
研究概览
简要总结
The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion.
详细描述
Patients will be treated in compliance with the eligibility criteria, with stent study of 16-19mm. All patients are clinically followed for 60 months after the procedure and will undergo a control angiography 6 months. Can be treated multiple lesions, measuring between 2.5-3.5mm (by visual estimate). Patients enrolled will be randomized in a 1:2 propose in one of the groups with or without stent coating, respectively. And a randomized clinical trial, prospective study in 5 centers including 60 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years and ≤75 years;
- •Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
- •Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
- •Target lesion located in a native coronary artery;
- •Target lesion in vessel with diameter ranging from 2.5 to 3.5 mm (by visual estimate) amenable to treatment (coverage) with a 16- 19mm-long stent;
- •Target lesion with >50% diameter stenosis (by visual estimate);
- •Acceptable candidate to myocardial revascularization surgery (coronary artery bypass graft surgery);
- •The subject has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
排除标准
- •Female patients of childbearing potential;
- •Recent Q-wave myocardial infarction occurred within 48 hours prior to the index procedure. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers;
- •Documented left ventricular ejection fraction <30%;
- •Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
- •Platelet count <100,000 cells/mm³ or >700,000 cells/mm³.;
- •White blood cell count <3,000 cells/mm3;
- •Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
- •Heart transplant receptor;
- •Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
- •Concurrent medical condition with a life expectancy of less than 12 months;
- •Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study;
- •Subject is currently participating in an investigational drug or another device study, including planned participation in an investigational drug or another device study during the course of the present investigation;
- •Coronary angioplasty (with or without stenting) less than 9 months before the index procedure at any site of the target vessel;
- •Previous coronary angioplasty (with or without stenting) at any time (>9 months) in a vessel segment less than 5 mm proximal or distal to the target lesion.
- •Planned coronary angioplasty (with or without stenting) in the first 12 months after the index procedure in any segment of the target vessel;
- •ANGIOGRAPHIC EXCLUSION CRITERIA
- •Restenotic target lesion;
- •More than one lesion requiring treatment in the same vessel;
- •Target vessel diameter <2.5 mm or >3.5 mm (by visual estimation);
- •Long target lesion not amenable to treatment (coverage) with a 16-19mm long stent;
- •Unprotected coronary artery branch lesion (≥50% diameter stenosis)
- •Target lesion is located in a surgical bypass graft;
- •Total vessel occlusion (TIMI flow grade 0-1);
- •Target lesion with ostial location;
- •Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral branch stenting;
- •Calcified target lesion that anticipates unsuccessful/impracticable predilation;
- •Target vessel with excessive tortuosity
结局指标
主要结局
Lumen Loss
时间窗: 6 months after the procedure
For an accurate assessment of the stent conditions 6 months after implantation, a follow-up catheterization will be performed at the 6-month visit in order to measure the diameter of the artery at the stented site. The objective is the lumen loss in-segment (including the portion in-stent and edges of 5 mm proximal and distal) at 6 months.
次要结局
- Adverse Cardiac Events(30 days, 6, 12 and 60 months after the procedure)
研究者
研究点 (8)
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