GLYCAR STUDY is a Post Market Multicenter clinical investigation of GLYCAR Bovine pericardial patch with EnCap™ Technology in cardiac and vascular repair or reconstruction surgery. The main objective of this study is to collect real-world, long term clinical data in 100 adult and pediatric patients in whom GLYCAR Pericardial patch is used for: pericardial closure, cardiac and great vessel reconstruction and repair, peripheral vascular reconstruction and repair.
Sponsor
Primary endpoints
1. Incidence of Glycar Pericardial patch related mortality [Time Frame: 30 days post procedure or hospital discharge (whichever comes first)]
2. Incidence of Glycar Pericardial patch related reintervention [Time Frame: 30 days post procedure or hospital discharge (whichever comes first)]
CERC Services
- CEC activities
- CIP & ICF review
- CoreLab activities
- EDC and data management
- Monitoring activities
- Project management
- Regulatory submissions
- SAE Reporting
- Statistical Analysis
- Study documents draft and review
Countries
France, Germany, South Africa
Number of investigational sites
10 to 12 sites
Number of patients
120
