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Recruiting NCT07161583

Advanta VXT and Flixene PMCF Registry

Trial Parameters

Condition Peripheral Arterial Disease
Sponsor Atrium Medical Corporation
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-25
Completion 2026-09
Interventions
Advanta VXT Vascular GraftFlixene Vascular Graft

Brief Summary

The purpose of the registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries. This registry is also intended to provide further data on the clinical usefulness of the Advanta VXT and Flixene vascular grafts.

Eligibility Criteria

Inclusion Criteria: * Willing, and able to provide legally-effective written informed consent (as required by IRB/EC) * Male and female patients that have undergone replacement or repair of the peripheral arteries using the Advanta VXT or Flixene vascular graft. * Were at least 18 years of age at the time of the procedure * Available records for data collection, with a minimum of 36 months of data/follow-up. Exclusion Criteria: \- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft

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