Multicenter Prospective Clinical Study of the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 发起方
- Stentys
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Efficacy Endpoint - Angiographic Success
研究概览
简要总结
Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left main coronary artery disease.
详细描述
In the treatment of unprotected left main coronary artery (ULMCA) disease, previous mono-center studies have shown promising results with the previous generation of the self-expandable STENTYS stent (paclitaxel eluting stent, delivered via withdrawal of a sheath).
The TRUNC study aims at assessing at large scale the Xposition S in the treatment of ULMCA disease. The Xposition S is a sirolimus eluting stent, mounted on a balloon delivery system. The study aims at collecting clinical practice routine data from 200 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject ≥ 18 years old;
- •Presence of coronary artery stenosis in the unprotected Left Main (LM) Coronary Artery which is indicated for PCI and Xposition S stent treatment
- •Left Main Coronary Artery reference vessel diameter ranging from 2.5 mm to 6.0 mm;
- •The subject is able to provide voluntary informed consent, willing to comply with all study requirements and sign the written informed consent.
排除标准
- •Recent STEMI (<1 month) ;
- •SYNTAX score ≥ 33 ;
- •Highly calcified lesions or excessive tortuosity at target lesion site;
- •Subject unable to comply with dual antiplatelet therapy as recommended per guidelines;
- •Planned cardiac surgery or valve intervention within the next 12 months.
- •Participation to other investigational drug or device studies that have not reached their primary endpoint.
结局指标
主要结局
Efficacy Endpoint - Angiographic Success
时间窗: 12 months post-procedure
Achievement of \<20% final residual stenosis at target lesion (visual estimation) with TIMI 3 flow in main branch
Clinical Endpoint- Target Lesion Failure (TLF)
时间窗: 12 months post-procedure
TLF defined as cardiac death, MI not attributable to a non target vessel, or clinically driven target lesion revascularization
次要结局
- Procedural Success(48 hours post procedure (hospital discharge))
- Clinically Driven Target Lesion Revascularization(30 days, 12 months and 24 months post procedure)
- MI rate (not attributable to a non target vessel)(30 days, 12 months and 24 months post procedure)
- Stroke Events Rate(30 days, 12 and 24 months post procedure)
- TLF(30 days post procedure)
- Cardiac Death Rate(30 days, 12 months and 24 months post procedure)
- Fluoroscopy Time, during Index Procedure(End of the index procedure)
- Minimal Lumen Area by IVUS (IVUS substudy)(End of the index procedure)
- Stent Thrombosis Events Rate(30-day, 12-month and 2 year post-procedure)
- Index Procedure Duration(End of the index procedure)
- Acute Stent Malappositon by IVUS (IVUS Substudy)(End of the index procedure)