XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- In-stent neointimal volume
研究概览
简要总结
The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty
详细描述
The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment
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 (Outcomes Assessor)
盲法说明
The members of the Event Adjudication Committee and the Core Lab will be blinded to the patient assignment.
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
- •Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI.
- •PCI considered appropriate and feasible
- •Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length);
- •Patient provides written informed consent
- •Patient agrees to all required follow-up procedures and visits.
- •Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm
排除标准
- •The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
- •Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum;
- •Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer;
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods;
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
- •Previous coronary intervention on target vessel in the 3-months prior to enrollment;
- •Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- •Previously documented left ventricular ejection fraction (LVEF) <30%;
- •Evident cardiogenic shock before randomization;
- •Patients with left main stem stenosis (>50% by visual estimate);
- •In-stent restenosis;
- •ST-segment elevation MI;
- •Chronic total occlusion/ heavily calcified lesions
- •Culprit lesion to a Saphenous Vein graft
结局指标
主要结局
In-stent neointimal volume
时间窗: 6-month follow-up
In-stent neointimal volume at 6-month follow-up, measured with OCT, as assessed by the Core-Lab. Neointimal volume will be calculated in all analyzed cross-sections and volumetric measurements and in stent neointimal volume will be compared in the two groups.
次要结局
- Neointimal area(6-month follow-up)
- Number of Target lesion failure(12-months follow-up)
- Percentage of Lesion success at 24 hours(24 hours)
- Number of Stent thrombosis(12-months follow-up)
- Percentage of Procedural success at 24 hours(24 hours)
- Number of patients experiencig Cardiac death(12-months follow-up)
- Percentage of Device success at 24 hours(24 hours)
- Number of Target-vessel Myocardial infarction(12-months follow-up)
- Number of Target-lesion revascularization(12-months follow-up)