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NCT05661981
GLYCAR Post Market Multicenter Study
Conditions: Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
Sex: All
Enrollment: 100
Sponsor: GLYCAR SA (Pty) Ltd
Summary
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
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 participationIntraprocedural 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.
Source: ClinicalTrials.gov (NCT05661981). StuddyBuddy aggregates publicly available trial information.