Long-Term Follow-up Study of ROADSTER 3 Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 197
- 试验地点
- 74
- 主要终点
- In-stent Restenosis
研究概览
简要总结
The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).
详细描述
This is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System in the ROADSTER 3 study.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
- •Able to provide informed consent
排除标准
- •Participants who have exited the ROADSTER 3 study early (i.e., prior to completion of protocol required follow-up) will not participate in the sub-study
研究组 & 干预措施
Standard-risk patients who underwent carotid intervention
Symptomatic or asymptomatic patients with a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA), who underwent carotid artery revascularization.
干预措施: Transcarotid Artery Revascularization (TCAR) (Procedure)
结局指标
主要结局
In-stent Restenosis
时间窗: 2-years and 5-years following the index procedure
In-stent restenosis ≥70% at 2-years and 5-years
Ipsilateral Stroke Mortality
时间窗: 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral stroke mortality at 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral Stroke
时间窗: 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure
次要结局
未报告次要终点