A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change rate of restenosis
研究概览
简要总结
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.
A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty
- •Subjects ≥ 18 years old
排除标准
- 未提供
结局指标
主要结局
Change rate of restenosis
时间窗: within 30 days after surgery and long term (up to 1 year after surgery )
Measure assessing change target-artery restenosis (defined as 70% or more diameter-reducing stenosis), occlusion, or re-intervention within 1 year after surgery using POLYPATCH®
次要结局
- Operation time(up to 24 weeks)
- occurrence of other complications(within 30 days after surgery and long term (up to 3 years))
- mortality (cardiovascular and all causes)(within 30 days after surgery and long term (up to 3 years))
- myocardial infarction(3 years)
- Procedural success rate(within 30 days after surgery and long term (up to 1 year after surgery ))
- target-artery restenosis Target-artery restenosis(within 30 days after surgery and long term (up to 3 years))
- target-artery re-intervention(within 30 days after surgery and long term (up to 3 years))
- transient ischemic attack(3 years)
- stroke (ipsilateral and any)(within 30 days after surgery and long term (up to 3 years))