NCT03484234终止不适用
A Multi-center, Randomized, Study to Compare the Effectiveness of Sirolimus-eluting Stent (Ultimaster Stent) or Everolimus-eluting Stent (XIience Alpine Stent) for Long Coronary Lesions.
Seung-Jung Park2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年7月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- In-segment late luminal loss
研究概览
简要总结
This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 19 years of age.
- •Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
- •Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
- •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus
- •An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
- •Acute ST-segment-elevation MI or cardiogenic shock
- •Terminal illness with life expectancy <1 year
- •In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
- •Patients with EF<30%.
- •Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.
- •Patients with left main stem stenosis (>50% by visual estimate)
研究组 & 干预措施
Ultimaster stent
Experimental
干预措施: Ultimaster stent (Device)
Xience alpine stent
Active Comparator
干预措施: Xience alpine stent (Device)
结局指标
主要结局
In-segment late luminal loss
时间窗: 13-month
次要结局
- Target vessel revascularization (ischemia-driven and clinically-driven)(1 year)
- Target-vessel failure(1 year)
- All death(1 year)
- Composite of death or MI(1 year)
- In-stent late loss(13-month)
- Stent thrombosis(1 year)
- Volume of intimal hyperplasia(13-month)
- Myocardial infarction (MI)(1 year)
- In-stent and in-segment restenosis(13-month)
- Angiographic pattern of restenosis(13-month)
- Cardiac death(1 year)
- Composite of cardiac death or MI(1 year)
- Target lesion revascularization (ischemia-driven and clinically-driven)(1 year)
- Incidence of late stent malapposition(13-month)
- Procedural success(5 days)
研究者
Seung-Jung Park
Professor, Division of Cardiology
Asan Medical Center
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)Distal Radial ArteryRadial Artery OcclusionCoronary Artery DiseaseNCT05253820Wujin People's Hospital801
已完成
4 期
YUKON Choice Versus TAXUS Liberté in Diabetes MellitusCoronary ArteriosclerosisNCT00368953University of Leipzig240
终止
不适用
A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCTCoronary Artery DiseaseNCT00350506GE Healthcare77
终止
不适用
Treatment Decisions for Multi-vessel CADCoronary Artery DiseaseNCT02611050Dartmouth-Hitchcock Medical Center14
撤回
不适用
DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular ScaffoldCoronary RestenosisCoronary Artery DiseaseNCT03074305Samsung Medical Center