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Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Intervascular Vascular Grafts and Patches in Patients Undergoing Bypass, Replacement, or Repair of Aortic, Peripheral, or Carotid Arteries
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- 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 (device)
Sponsor: Intervascular · Participants: 1,200 · Started: Dec 19, 2025
Contact the study team
- Senior Manager, Clinical Affairs · Phone: +1 603 233 7685
Official record on ClinicalTrials.gov — NCT07322913
Locations in the U.S.
| Pennsylvania | The Pennsylvania State University and The Milton S. Hershey Medical Center, Hershey Allegheny General Hospital, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.