GLYCAR Post Market Multicenter Study (CIP002)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Congenital Premature Cardiac Closure; Cardiac and Great Vessel Reconstruction and Repair; Peripheral Vascular Reconstruction and Repair
• Intervention / Treatment: Device: GLYCAR Pericardial Patch

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.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

Study Locations

• France
  • Le Plessis-Robinson, France
    • Marie Lannelongue Hospital
• Germany
  • Leipzig, Germany
    • Leipzig Heart Institute GmbH
  • Munich, Germany
    • German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section
  • Munich, Germany
    • German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• No study specific exclusion criteria: patients treated per standard clinical practice and do not present any of the contraindications detailed in the IFU.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult and pediatric patients; Undergoing cardiac and/or vascular repair or reconstruction surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Glycar Pericardial patch related mortality	Patch related mortality at long term follow up will be determined	1- and 2-years post-procedure
Incidence of Glycar Pericardial patch related reinterventions	Patch related reintervetion at long term follow up will be determined	1- and 2-years post-procedure
Total number of unplanned reoperations required in patients	The total number of unplanned reoperations required in patients over the FU period which include the repair or alteration of the surgical area around the patch. (Patients with planned reoperations at the time of the primary index procedure will not be considered)	30 days post procedure or hospital discharge (whichever comes first), 1- and 2-years post-procedure
Incidence of thrombus formation	Number of thrombus formed post procedure will be taken in to account	30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up
Incidence of Glycar Pericardial Patch related unanticipated adverse events	Incidence rate of unanticipated adverse events reported for this patch during the FU period will be reported	30 days or hospital discharge (whichever comes first) and 1- and 2-years follow-up
Rate of detected Patch infection (such as endocarditis)	Any patch related infection rate will be analyzed	30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up

Collaborators and Investigators

• Sponsor: GLYCAR SA (Pty) Ltd
• Investigators: Principal Investigator: Julien Guihaire, Cardiac Surgeon, Head of Heart Transplantation and Mechanical Circulatory Support Program

Publications and helpful links

General Publications

• Bedard DL, Unterman R, Bopp LH, Brennan MJ, Haberl ML, Johnson C. Rapid assay for screening and characterizing microorganisms for the ability to degrade polychlorinated biphenyls. Appl Environ Microbiol. 1986 Apr;51(4):761-8. doi: 10.1128/aem.51.4.761-768.1986.
• Hackam DJ, Rotstein OD. Stoma closure and wound infection: an evaluation of risk factors. Can J Surg. 1995 Apr;38(2):144-8.
• Featherstone HJ. Headaches and heart disease: the lack of a positive association. Headache. 1986 Jan;26(1):39-41. doi: 10.1111/j.1526-4610.1986.hed2601039.x. No abstract available.
• Okada N, Wada K, Goldsmith BA, Koizumi S. SHP-2 is involved in neurotrophin signaling. Biochem Biophys Res Commun. 1996 Dec 13;229(2):607-11. doi: 10.1006/bbrc.1996.1851.
• Figdor PP, Todoroff K, Wiltschke H. [Acute renal failure in dysglobulinemias (multiple myeloma and amyloidosis)]. Urol Int. 1967;22(5):390-8. doi: 10.1159/000279503. No abstract available. German.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Bovine pericardial patch
• Other Study ID Numbers: GLYCAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No