A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Incidence of Glycar- Pericardial patch related mortality
研究概览
简要总结
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
详细描述
This real-world, single-arm, multi-center, observational, non-interventional prospective registry will enroll up to 100 consecutive subjects undergoing cardiac and/or vascular repair or reconstruction surgery in 10-12 investigative sites in the European Union (EU), South Africa and USA. The study is aimed at providing real-world evidence of the Glycar Pericardial patch device performance and incidence of clinical outcomes in patients undergoing cardiac and/or vascular repair or reconstruction surgery related to Glycar Pericardial patch.
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
- •Patients (to be) treated with Glycar Pericardial patch as per IFU and standard clinical practice.
- •The patient or patient's legal representative signs an EC/ IRB approved informed consent form prior to the study participation
- •Intraprocedural inclusion:
- •GLYCAR Pericardial Patch was implanted, or implantation attempted during the index procedure.
排除标准
- •No study specific exclusion criteria: patients treated per standard clinical practice and do not present any of the contraindications detailed in the IFU.
结局指标
主要结局
Incidence of Glycar- Pericardial patch related mortality
时间窗: 30 days post procedure or hospital discharge (whichever comes first)
Patch related mortality at acute follow up will be determined
Incidence of Glycar- Pericardial patch related reintervention
时间窗: 30 days post procedure or hospital discharge (whichever comes first)
Patch related re-intervention at acute follow up will be determined
次要结局
- Incidence of Glycar Pericardial patch related reinterventions(1- and 2-years post-procedure)
- Incidence of Glycar Pericardial patch related mortality(1- and 2-years post-procedure)
- Total number of unplanned reoperations required in patients(30 days post procedure or hospital discharge (whichever comes first), 1- and 2-years post-procedure)
- Incidence of thrombus formation(30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up)
- Incidence of Glycar Pericardial Patch related unanticipated adverse events(30 days or hospital discharge (whichever comes first) and 1- and 2-years follow-up)
- Rate of detected Patch infection (such as endocarditis)(30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up)