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NCT07322913Recruiting

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

Intervascular

Start Date

12/19/2025

Completion Date

12/1/2026

Summary

The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement of aortic, peripheral, or carotid arteries. This registry is intended to further define the expected product lifetime of the devices and to collect data related to usefulness of the antimicrobial coatings.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Willing, and able to provide legally-effective written informed consent (as required by Institutional Review Board or Ethics Committee) * Male and female patients that have undergone bypass, replacement or repair of the peripheral arteries, aorta, or carotid artery using the Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) * Were at least 18 years of age at the time of the procedure * Available records for data collection with a minimum of 3 years (36 months) of data/follow-up. Exclusion Criteria: * Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.

Interventions

DEVICE

Intergard Standard - Collagen Coated Vascular Grafts and Patches

DEVICE

Hemashield - Collagen Coated Vascular Grafts and Patches

DEVICE

Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches

DEVICE

Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts

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Conditions

Carotid Artery DiseasesAortic DiseasesPeripheral Arterial Diseases

Locations

The Pennsylvania State University and The Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

CHU Dijon Bourgogne

Dijon,

France

Hospital Universitario de Navarra

Pamplona,

Spain