NCT07161583

Advanta VXT and Flixene PMCF Registry

Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Atrium Advanta VXT and Flixene Vascular Grafts in Patients Undergoing Surgical Repair or Replacement of Peripheral Arteries

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Atrium Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Advanta VXT Vascular Graft	The Advanta VXT graft is a two (2)-layer graft employing a single layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. Some Advanta VXT configurations include Helix, which is a monofilament bead wrapped circumferentially around a portion or the entire length of the graft (such a graft is also called a Ringed Graft). The helix rings are bonded to the exterior surface of the graft. Advanta VXT Tapers are formed by changing the graft diameter, expanding from a small Inner Diameter (ID) to a larger ID (with the result that one end is larger).
DEVICE	Flixene Vascular Graft	The Flixene vascular graft is a three (3)-layered graft comprised of ePTFE. The Flixene graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary

Timeline

• Start date: 2025-09-25
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2025-09-08
• Last updated: 2026-03-13

Locations

2 sites across 2 countries: United States, France

Regulatory

• FDA-regulated device study