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Active, Not Recruiting

NCT Number: NCT05661981

GLYCAR Post Market Multicenter Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Marie Lannelongue Hospital, Le Plessis-Robinson, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Glycar- Pericardial patch related mortality

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

    Patch related mortality at acute follow up will be determined

  2. Incidence of Glycar- Pericardial patch related reintervention

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

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

Secondary outcomes

  1. Incidence of Glycar Pericardial patch related mortality

    Time frame: 1- and 2-years post-procedure

    Patch related mortality at long term follow up will be determined

  2. Incidence of Glycar Pericardial patch related reinterventions

    Time frame: 1- and 2-years post-procedure

    Patch related reintervetion at long term follow up will be determined

  3. Total number of unplanned reoperations required in patients

    Time frame: 30 days post procedure or hospital discharge (whichever comes first), 1- and 2-years post-procedure

    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)

  4. Incidence of thrombus formation

    Time frame: 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up

    Number of thrombus formed post procedure will be taken in to account

  5. Incidence of Glycar Pericardial Patch related unanticipated adverse events

    Time frame: 30 days or hospital discharge (whichever comes first) and 1- and 2-years follow-up

    Incidence rate of unanticipated adverse events reported for this patch during the FU period will be reported

  6. Rate of detected Patch infection (such as endocarditis)

    Time frame: 30 days or hospital discharge (whichever comes first) and 1- and 2- year follow-up

    Any patch related infection rate will be analyzed

Sponsors and collaborators

Lead sponsor

GLYCAR SA (Pty) Ltd

Industry

Registry information

Official study 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

Acronym: CIP002

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.