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
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