NCT00936780终止4 期
Safety and Efficacy of the Infinnium-Core™ Paclitaxel-Eluting Coronary Stent System for the Treatment of Patients With De Novo Coronary Lesions
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 14
- 主要终点
- Major Adverse Cardiac Events (MACE)
研究概览
简要总结
The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.
详细描述
Infinnium-Core™ Registry is a multi-centric, prospective study. Approximately 150 patients will be enrolled in the study. Patients will be followed for two years post-procedure.
Data analysis will include all statistically pre assigned 20% patients and all patients who have repeat angiography due to complication. The diabetic patients will be specified as a high risk subset in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Eligible for percutaneous coronary intervention (PCI).
- •Acceptable candidate for CABG.
- •Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1,2,3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
- •The target lesion is a single de novo coronary artery lesion with ≥ 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
- •The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
- •The target lesion must be ≤ 37 mm in length by visual estimate.
- •The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
- •Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.
排除标准
- •Female of childbearing potential.
- •Documented left ventricular ejection fraction (LVEF) ≤ 25%.
- •Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure.
- •Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, paclitaxel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated).
- •A platelet count <100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm
- •Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L).
- •Target vessel has evidence of thrombus.
- •Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.
- •Previous bare metal stenting (less than 1 year) anywhere within the target vessel.
- •Previous drug-eluting stenting anywhere within any epicardial vessel
- •The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g., but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
- •Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off.
- •Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.
- •Target lesion is located in or supplied by an arterial or venous bypass graft.
- •Ostial target lesion.
- •Patient is currently participating in an investigational drug or device study, including its follow-up period.
- •Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind.
- •Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
- •CVA within previous 6 months.
- •Unprotected Left Main (LM) coronary artery disease (stenosis > 50%).
- •In the investigator's opinion, patient has a co-morbid 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.
- •Planned surgery within 6 months after the index procedure.
- •Life expectancy less than 1 year.
研究组 & 干预措施
Infinnium-Core™ Paclitaxel eluting Coronary Stent
Experimental
干预措施: Infinnium-Core™ Paclitaxel eluting Coronary Stent (Device)
结局指标
主要结局
Major Adverse Cardiac Events (MACE)
时间窗: 30 days and 9 month
次要结局
- ANGIOGRAPHIC(12 months)
研究者
研究点 (14)
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