Advanta VXT and Flixene PMCF Registry

Recruiting now

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT07161583

Run by

Atrium Medical Corporation

People needed

1000

Starts

2025-09-25

Expected to finish

2026-10-01

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• CHU de Brest — Brest, Brittany Region, France (enrolling)

Full record on ClinicalTrials.gov

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