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
- 28
- 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
- •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/
排除标准
- •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 ≤ 22 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 approved by the Institutional Review Board/Ethics Committee of the clinical site.
- •Exclusion Criteria:
- •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
研究组 & 干预措施
Supralimus(R) Sirolimus Eluting Stent
Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2
干预措施: Supralimus(R) Sirolimus-Eluting Coronary Stent System (Device)
Xience V™ Everolimus Eluting Stent
The XIENCE V™ Everolimus Eluting Coronary Stent System consisting of the MULTI-LINK VISION® Coronary Stent System coated with a formulation containing everolimus, the active ingredient, embedded in a non-erodible polymer., Drug Load: 100 µg/cm2
干预措施: Xience V™ Everolimus Eluting Coronary Stent (Device)
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)