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

Recruiting now

Conditions studied: Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases

In brief

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.

Key facts

Study ID

NCT07322913

Run by

Intervascular

People needed

1200

Starts

2025-12-19

Expected to finish

2026-12-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.

Where it is running

• The Pennsylvania State University and The Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• CHU Dijon Bourgogne — Dijon, France (enrolling)
• Hospital Universitario de Navarra — Pamplona, Spain (enrolling)

Full record on ClinicalTrials.gov

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