Advanta VXT and Flixene PMCF Registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: An approximate 1,000 patients from 25 sites across the US and Europe will participate in this registry. The number of patients and sites included will ensure a representation of the overall population, specifically in vascular surgery. No mandated procedures, assessments or visits will be implemented, given the non-interventional nature of the registry.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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

Conditions

Peripheral Arterial Disease

Being tested

Advanta VXT Vascular Graft, Flixene Vascular Graft

Medical subject headings

Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Advanta VXT Vascular GraftDevice

  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).

• Flixene Vascular GraftDevice

  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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Percentage of Participants meeting Primary Efficacy Endpoint

   Primary patency defined as freedom from graft occlusion or reintervention

   Measured: Procedure/surgery through registry completion (a minimum of 3 years)

2. Percentage of Participants meeting Primary Safety Endpoint

   Major Adverse Limb Events (MALE), defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis

   Measured: Procedure/surgery through registry completion (a minimum of 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Sep 2025
2. Study start25 Sep 2025
3. Primary completionDec 2027 (estimated)
4. Study completionDec 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.