A Post Market Multicentre Retrospective Study of Glycar Bovine Pericardial Patch With AldeCaptm Technology (Aka SJM With EnCaptm Technology) in Cardiac and Vascular Repair or Reconstruction Surgery (CIP-003)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The overall purpose of this observational Post Market Clinical Follow Up (PMCF) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.
详细描述
To comply with Medical Device Regulation (MDR) Post Market Clinical Follow Up (PMCF) requirements through proactive ongoing assessment of the safety, efficacy, and performance of the commercially available Glycar Pericardial Patch in patients undergoing cardiovascular repair or reconstruction surgery.
This real-world evidence retrospective data collection single-arm multicentre, observational, non-interventional study will enrol up to a minimum of 50 consecutive participants who meet inclusion criteria, in 2-3 centres. The study is aimed at providing real-world evidence of the Glycar Pericardial patch.
Retrospective data analysis will include collected clinical data from consecutive participants with a minimum of 2 years follow up, meaning from 30 June 2020 and going back in time. The quality of medical history being recorded is believed to be more reliable and complete in the most recent years. Therefore, it was decided to start enrolling consecutive participants in a reverse chronological order.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If no waiver has been granted by the Ethics committee: Participants (all age) or legal guardian has signed the informed consent
- •Participant has undergone a cardiac or vascular procedure which falls within the indications for use and required the use of Glycar Pericardial Patch
排除标准
- •There are no study specific exclusion criteria. Participants have already been treated per standard clinical practice.
结局指标
主要结局
Mortality
时间窗: Within < 30 days post procedure
Incidence of patch related mortality
Reintervention
时间窗: Within < 30 days post procedure
Incidence of patch related reintervention
次要结局
- Reintervention(Up to 2 years)
- Thrombus formation(Within < 30 days post procedure)
- Mortality(Up to 2 years)
- Unplanned reoperations(Up to 2 years)
- Infection(Up to 2 years)
- Unanticipated AEs(Up to 2 years)