Post-Market Registry in Europe and US for the Use of VascuCelTM
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Incidence of graft related reintervention
研究概览
简要总结
This is a post-market, multi-centre, open-label registry designed to collect prospective safety and performance data on the use of VascuCel in patients who require great vessel reconstruction, peripheral vascular reconstruction or suture line buttressing. This registry will collect safety and performance data up to 2 years following implantation.
详细描述
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of VascuCel in patients with vascular disorders and in accordance with local standard of care. The Registry has been designed to collect data up to 2 years following implantation. The VascuCel Registry will collect data on the use of the VascuCel, for the following major indications:
- Great vessel reconstruction
- Peripheral vascular reconstruction
As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess device's safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient has signed the informed consent
- •patient is a candidate for treatment with VascuCel per approved device indications.
排除标准
- •no study specific exclusion criteria; patients treated per standard clinical practice
结局指标
主要结局
Incidence of graft related reintervention
时间窗: 30 days post procedure.
collect data on the number of incidence of graft related reintervention
Incidence of patch related morbidity
时间窗: 30 days post procedure.
collect data on patch related morbidity
次要结局
- incidence of unanticipated and rare events(at 30 days and 1 and 2 years follow-up)
- incidence of Patch retraction(at 30 days and 1 and 2 years follow-up)
- incidence of Patch dehiscence(at 30 days and 1 and 2 years follow-up)
- Incidence of graft related reintervention(at 1 and 2 years post procedure.)
- Rates of restenosis(at 30 days and 1 and 2 years follow-up)
- incidence of Patch calcification(at 30 days and 1 and 2 years follow-up)
- Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular location(at 30 days and 1 and 2 years follow-up)