Sponsor Name

GLYCAR SA.

Brief summary

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.

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

• CIP review and finalization​
• CRF and ICF Preparation​
• Project management​
• Regulatory submission​
• Sites’ selection​ and Sites’ contract management​
• Corelab​
• EDC and data management​
• Monitoring activities​
• SAE reporting
• CEC activities
• Statistical analysis ​
• Final clinical report​
• Study document​

Countries

France, Germany, South Africa, and United States of America (USA)

Number of investigational sites: 10 to 12 sites

Number of patients: 100