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Recruiting
NCT07322913
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
Conditions: Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1200
Sponsor: Intervascular
Location: The Pennsylvania State University and The Milton S. Hershey Medical Center Hershey Pennsylvania
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
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.
Source: ClinicalTrials.gov (NCT07322913). StuddyBuddy aggregates publicly available trial information.