GLYCAR Post Market Multicenter Study (CIP002)

Glycar

Status

Active, not recruiting

Conditions

Peripheral Vascular Reconstruction and Repair

Cardiac and Great Vessel Reconstruction and Repair

Congenital Premature Cardiac Closure

Treatments

Device: GLYCAR Pericardial Patch

Study type

Observational

Funder types

Industry

Identifiers

NCT05661981

GLYCAR

Details and patient eligibility

About

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

Full 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.

Enrollment

110 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.