A Randomized Comparison of the Supralimus® Stent With the Xience V™ Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 55
- 主要终点
- In-stent luminal late loss at 9 months after stent implantation (off-line QCA).
研究概览
简要总结
The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.
详细描述
Series III Run-In is a prospective, multi-center, randomized, single-blind (patient-blind), non-inferiority trial to be conducted at approx. 35 interventional cardiology centers in India, Brazil, Argentina, Thailand and Saudi Aurabia. A total of 360 will be randomized on a 2:1 basis to either the Supralimus® (sirolimus-eluting) stent or the Xience V™ (everolimus-eluting) stent.
In selected sites, IVUS will also be recorded in these patients (maximum of 60 IVUS patients in total), at baseline (post-procedure) and at 9-month follow-up.
All patients will be followed clinically for up to 5 years after stent implantation. Repeat angiography will be performed in all patients at 9 months after the index procedure.
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
- Single (Participant)
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
- 未提供
排除标准
- •Female of childbearing potential
- •Documented left ventricular ejection fraction (LVEF) ≤ 30%
- •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, sirolimus, everolimus, stainless steel, 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/mm3
- •Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L)
- •Total occlusion (TIMI 0) or TIMI 1
- •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
- •Target lesion involves a side branch >2.0mm in diameter with an ostial disease
- •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.
- •Stroke or transient ischemic attack within the prior 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
结局指标
主要结局
In-stent luminal late loss at 9 months after stent implantation (off-line QCA).
时间窗: 9 months
次要结局
- PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate(Hospital discharge)
- ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate(9 months)
- IVUS (in a subset of patients): Minimal lumen area, Vessel volume, Lumen volume, Neointimal hyperplasia, Volume obstruction, Incomplete stent apposition, Plaque behind the stent struts(9 months)
- DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR)(30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years)
- PATIENT-ORIENTED COMPOSITE ENDPOINT : All-cause death, Any MI (including non-target vessel territory), Any repeat revascularization (including all target and non-target vessel)(30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years)
- STENT THROMBOSIS(30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years)