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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
CHU Dijon Bourgogne
Dijon, France
Hospital Universitario de Navarra
Pamplona, Spain
Start Date
December 19, 2025
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
March 12, 2026
1,200
ESTIMATED participants
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
Lead Sponsor
Intervascular
NCT07078383
NCT04005976
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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