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Advanta VXT and Flixene PMCF Registry

NCT07161583 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-03-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Atrium Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Director, Clinical Affairs · Getinge

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2026-09-30
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07161583 on ClinicalTrials.gov