GLYCAR Post Market Multicenter Study

NCT05661981 | Active Not Recruiting DMC FDA Device

• 1 other identifier: GLYCAR
• Study Type: observational
• Target: 110
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

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

Keywords

Bovine pericardial patch

Outcome Measures

Primary Outcomes (2)

• Incidence of Glycar- Pericardial patch related mortality

  Patch related mortality at acute follow up will be determined

  30 days post procedure or hospital discharge (whichever comes first)

• Incidence of Glycar- Pericardial patch related reintervention

  Patch related re-intervention at acute follow up will be determined

  30 days post procedure or hospital discharge (whichever comes first)

Secondary Outcomes (6)

• Incidence of Glycar Pericardial patch related mortality

  1- and 2-years post-procedure

• Incidence of Glycar Pericardial patch related reinterventions

  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

Study Arms (1)

Adult and pediatric patients

Undergoing cardiac and/or vascular repair or reconstruction surgery

Device: GLYCAR Pericardial Patch

Interventions

GLYCAR Pericardial Patch DEVICE

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.

Adult and pediatric patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This real-world, single-arm, multi-center, observational, non-interventional prospective registry will enrol up to a total of 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.

You may qualify if:

• 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
• GLYCAR Pericardial Patch was implanted, or implantation attempted during the index procedure.

Sponsors & Collaborators

• GLYCAR SA (Pty) Ltd: lead

Study Sites (4)

Marie Lannelongue Hospital

Le Plessis-Robinson, France

Location

Leipzig Heart Institute GmbH

Leipzig, Germany

Location

German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section

Munich, Germany

Location

German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section

Munich, Germany

Location

Related Publications (9)

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  PMID: 6081367 BACKGROUND

• Tsai JW, Ayubi FS, Rice RD, Zhang Z, Armstrong PJ. Permacol (porcine dermal collagen) and Alloderm (acellular cadaveric dermis) as a vascular patch repair for common carotid arteriotomy in a rabbit model. Ann Vasc Surg. 2009 May-Jun;23(3):374-81. doi: 10.1016/j.avsg.2008.10.004. Epub 2008 Dec 6.

  PMID: 19059755 BACKGROUND

• Chlupac J, Filova E, Bacakova L. Blood vessel replacement: 50 years of development and tissue engineering paradigms in vascular surgery. Physiol Res. 2009;58 Suppl 2:S119-S140. doi: 10.33549/physiolres.931918.

  PMID: 20131930 BACKGROUND

• Edenfield L, Blazick E, Eldrup-Jorgensen J, Healey C, Bloch P, Hawkins R, Aranson N, Nolan B. Outcomes of carotid endarterectomy in the Vascular Quality Initiative based on patch type. J Vasc Surg. 2020 Apr;71(4):1260-1267. doi: 10.1016/j.jvs.2019.05.063. Epub 2019 Sep 3.

  PMID: 31492613 BACKGROUND

• Burla L, Schwegler I, Weibel P, Weber M, Zientara A, Attigah N. Intraoperatively self-made bovine pericardial graft for portomesenteric reconstruction in pancreatic surgery. Langenbecks Arch Surg. 2020 Aug;405(5):705-712. doi: 10.1007/s00423-020-01920-0. Epub 2020 Jun 30.

  PMID: 32607839 BACKGROUND

Study Officials

• Julien Guihaire

  Cardiac Surgeon, Head of Heart Transplantation and Mechanical Circulatory Support Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 22, 2022
• Study Start: October 9, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

FR (1); DE (3)