NCT05661981

GLYCAR Post Market Multicenter Study

A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: GLYCAR SA (Pty) Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study

Detailed description

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.

Conditions

• Congenital Premature Cardiac Closure
• Cardiac and Great Vessel Reconstruction and Repair
• Peripheral Vascular Reconstruction and Repair

Interventions

Type	Name	Description
DEVICE	GLYCAR Pericardial Patch	The Glycar patches are intended to be used by surgeons specialized in the field of cardiovascular surgery. The patch is intended to be used for pericardial closure, or repair and/or reconstruction of cardiovascular structures by replacing missing tissue, reinforcing weakened tissue and providing extra strength to repair tissue during healing.

Timeline

• Start date: 2023-10-09
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2022-12-22
• Last updated: 2025-06-24

Locations

4 sites across 2 countries: France, Germany

Regulatory

• FDA-regulated device study