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

Recruitingn/aAges 18 Years - anyAllIntervascular
NCT07322913 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intergard Standard - Collagen Coated Vascular Grafts and Patches
  • Hemashield - Collagen Coated Vascular Grafts and Patches
  • Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches
  • Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts
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Where

5 sites
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, United States
Allegheny General Hospital
Pittsburgh, United States
UZ Leuven
Leuven, Belgium
CHU Dijon Bourgogne
Dijon, France
Hospital Universitario de Navarra
Pamplona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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