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Recruiting NCT07322913

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

Trial Parameters

Condition Carotid Artery Diseases
Sponsor Intervascular
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-19
Completion 2026-12
Interventions
Intergard Standard - Collagen Coated Vascular Grafts and PatchesHemashield - Collagen Coated Vascular Grafts and PatchesIntergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches

Brief 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.

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