Retrospective Monocentric, Observational PMCF - Study on the Performance and Safety of Uni-Graft® K DV Patch in Patients With Vascular Reconstructions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Restenosis Rate in postoperative Course
研究概览
简要总结
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. Previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. Thus, it is not surprising that there is a limited amount of published literature available describing the use of the Uni-Graft® K DV Patch in the clinical routine. Therefore, the aim of the present non-interventional study (NIS) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the Uni-Graft® K DV Patch.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •written informed consent
- •treated with Uni-Graft® K DV Patch for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery
排除标准
- •Use of the Uni-Graft® K DV Patch if allergies to components of the patch are known
- •Use of the Uni-Graft® K DV Patch in case of a known hypersensitive reaction to the patch and / or its components (e.g. polyethylene terephthalate).
- •No use of Uni-Graft® K DV Patch
- •Use of Uni-Graft® K DV Patch outside the intended use of the product at the date of application
结局指标
主要结局
Restenosis Rate in postoperative Course
时间窗: approximately up to 3 months after Implantation
Retrospective evaluation of restenosis rate from information documented in the patient file: the NASCET is an angiographic measurement recommended by the "North American Symptomatic Carotid Endarterectomy Trial"-Group. According to the NASCET-Method the grade of stenosis in relation to the diameter of the ACI distal to the stenosis in the area of the parallel arterial wall is measured.
次要结局
- Rate of postoperative nerve lesions(approximately up to 3 months after Implantation)
- Rate of patch related infections(approximately up to 3 months after Implantation)
- Rate of postoperative pseudoaneurysm(approximately up to 3 months after Implantation)
- Rate of Intraoperative stroke(intraoperatively)
- Rate of postoperative stroke(approximately up to 3 months after Implantation)
- Primary and secondary patency rate(approximately up to 3 months after Implantation)
- Postoperative bleeding(approximately up to 3 months after Implantation)
- Freedom of re-intervention rate(approximately up to 3 months after Implantation)