World-wide Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice
试验速览
- 阶段
- 不适用
- 发起方
- Stentys
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- TLF at 1 Year follow-up
研究概览
简要总结
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical practice.
详细描述
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S stent used in routine clinical practice. Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for elective percutaneous coronary interventions suitable for a self-expanding stent, can be included in the registry.
This registry will allow collecting data, and provide substantial information in a real world setting on patients with indications like lesions in vessels with diameter variance, large vessels, left main coronary artery, bifurcations, ectatic vessels, ...
WIN will enroll 750 patients from approximately 30 sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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;
- •Presence of de novo coronary artery stenosis of ≥50% in a coronary artery suitable for implantation of the XPOSITION S STENT;
- •Vessel reference vessel diameter > 2.5 mm and ≤ 6.0 mm without excessive tortuosity or diffuse distal disease;
- •The target lesion is suitable for a drug-eluting self-expanding stent indication, as assessed by investigator;
- •The target lesion is 10mm or longer;
- •The patient has been fully informed of the study, written informed consent as approved by the applicable Ethics Committee.
排除标准
- •Known pregnancy or breastfeeding;
- •Known contraindication or hypersensitivity to any stent components, any PCI-related material or drug.
- •Concurrent medical condition with a life expectancy < 12 months;
- •Currently participating in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with this study endpoints;
- •Subjects undergoing cardiopulmonary resuscitation or in cardiogenic shock
- •Treatment of in-stent restenosis at target lesion;
- •Use of bioabsorbable/bioresorbable stents
- •Target lesion in left main coronary artery is excluded only if any of the following conditions is met:
- •Ostial left main lesion;
- •Presence of severe calcifications
- •Vessel diameter is smaller than 3.0mm
结局指标
主要结局
TLF at 1 Year follow-up
时间窗: 1 year follow-up post-procedure
Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion Revascularization (TLR)
次要结局
- TLF at 2 Year(2 year follow-up post-procedure)
- TVF at 1 Year(1 year follow-up post-procedure)
- Acute success rates(From Index procedure up to hospital discharge (48 hours post procedure))
- Stent thrombosis(1-year and 2-year follow-up post procedure)