Clinical trial NCT05661981: GLYCAR Post Market Multicenter Study
Official title: A Post Market Multicenter Clinical Investigation of GLYCAR Bovine Pericardial Patch With EnCap™ Technology in Cardiac and Vascular Repair or Reconstruction Surgery. GLYCAR Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Premature Cardiac Closure
Cardiac and Great Vessel Reconstruction and Repair
Peripheral Vascular Reconstruction and Repair
Keywords: Bovine pericardial patch
Lead sponsor: GLYCAR SA (Pty) Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Glycar- Pericardial patch related mortality
timeFrame: 30 days post procedure or hospital discharge (whichever comes first)
measure: Incidence of Glycar- Pericardial patch related reintervention
timeFrame: 30 days post procedure or hospital discharge (whichever comes first)
Secondary outcomes:
measure: Incidence of Glycar Pericardial patch related mortality
timeFrame: 1- and 2-years post-procedure
measure: Incidence of Glycar Pericardial patch related reinterventions
timeFrame: 1- and 2-years post-procedure
measure: Total number of unplanned reoperations required in patients
timeFrame: 30 days post procedure or hospital discharge (whichever comes first), 1- and 2-years post-procedure
measure: Incidence of thrombus formation
timeFrame: 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up
measure: Incidence of Glycar Pericardial Patch related unanticipated adverse events
timeFrame: 30 days or hospital discharge (whichever comes first) and 1- and 2-years follow-up
measure: Rate of detected Patch infection (such as endocarditis)
timeFrame: 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Marie Lannelongue Hospital
city: Leipzig
country: Germany
facility: Leipzig Heart Institute GmbH
city: Munich
country: Germany
facility: German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section
city: Munich
country: Germany
facility: German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section
Study officials:
affiliation: Cardiac Surgeon, Head of Heart Transplantation and Mechanical Circulatory Support Program
name: Julien Guihaire
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li X, Guo Y, Ziegler KR, Model LS, Eghbalieh SD, Brenes RA, Kim ST, Shu C, Dardik A. Current usage and future directions for the bovine pericardial patch. Ann Vasc Surg. 2011 May;25(4):561-8. doi: 10.1016/j.avsg.2010.11.007. Epub 2011 Jan 28.
citation: Mei X, Cheng K. Recent Development in Therapeutic Cardiac Patches. Front Cardiovasc Med. 2020 Nov 27;7:610364. doi: 10.3389/fcvm.2020.610364. eCollection 2020.
citation: Bianchi G. eComment. Autologous pericardium is superior to conventional bovine patch in congenital heart disease reconstructive surgery: an appraisal for tissueengineered xenograft. Interact Cardiovasc Thorac Surg. 2013 Oct;17(4):702-3. doi: 10.1093/icvts/ivt368. No abstract available.
citation: Chlupac J, Matejka R, Konarik M, Novotny R, Simunkova Z, Mrazova I, Fabian O, Zapletal M, Pulda Z, Lipensky JF, Stepanovska J, Hanzalek K, Broz A, Novak T, Lodererova A, Voska L, Adla T, Fronek J, Rozkot M, Forostyak S, Kneppo P, Bacakova L, Pirk J. Vascular Remodeling of Clinically Used Patches and Decellularized Pericardial Matrices Recellularized with Autologous or Allogeneic Cells in a Porcine Carotid Artery Model. Int J Mol Sci. 2022 Mar 18;23(6):3310. doi: 10.3390/ijms23063310.
citation: Iop L, Palmosi T, Dal Sasso E, Gerosa G. Bioengineered tissue solutions for repair, correction and reconstruction in cardiovascular surgery. J Thorac Dis. 2018 Jul;10(Suppl 20):S2390-S2411. doi: 10.21037/jtd.2018.04.27.
citation: 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.
citation: 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.
citation: 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.
citation: 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.