STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- strut malapposition at six months measured by OCT
研究概览
简要总结
Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions.
Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention.
Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years;
- •CTO referred for PCI
- •Diameter of the Target vessel for PCI between 2.5 and 4.5mm
- •Agreement to participate and signed informed consent after information
- •Affiliation to Social Security System
- •French comprehension
排除标准
- •Pregnant women, breast-feeding,
- •History of an allergic reaction or significant sensitivity to any stent component or to contrast dye
- •Intrastent CTO
- •Major calcifications in the CTO
- •Inclusion in another interventional study
- •Person under guardianship or curatorship
研究组 & 干预措施
Stentys Xposition S Self-Apposing stent
STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System
干预措施: Implantation of Stent (PCI) (Device)
Conventional Balloon-expandable stent
Conventional Balloon-expandable drug eluting stents in effect at the time of the study, in compliance with applicable contracts made between Hospital and suppliers.
干预措施: Implantation of Stent (PCI) (Device)
结局指标
主要结局
strut malapposition at six months measured by OCT
时间窗: 6 months after CTO-PCI
次要结局
- Restenosis(6 months after CTO-PCI)
- percentage of uncovered struts(6 months after CTO-PCI)
- lumen diameter (mm)(6 months after CTO-PCI)
- Angina pectoris(6 months after CTO-PCI)
- Stroke(6 months after CTO-PCI)
- Stent thrombosis(6 months after CTO-PCI)
- Dyspnea(6 months after CTO-PCI)
- Mortality(6 months after CTO-PCI)