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NCT Number: NCT07161583

Advanta VXT and Flixene PMCF Registry

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.

Recruiting

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Brest, Brest, Brittany Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanta VXT Vascular Graft

Device

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 Graft

Device

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

Primary outcomes

  1. Percentage of Participants meeting Primary Efficacy Endpoint

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

    Primary patency defined as freedom from graft occlusion or reintervention

  2. Percentage of Participants meeting Primary Safety Endpoint

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

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

Secondary outcomes

  1. Incidence of Reported Complications/Events

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

  2. Percentage of Participants meeting Primary-Assisted Graft Patency

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

    Defined as freedom from graft occlusion irrespective of whether an intervention was performed; in other words, primary-assisted patency is not lost when a reintervention is performed to preserve graft patency before occlusion occurs

  3. Percentage of Participants meeting Secondary Graft Patency

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

    Defined as freedom from "permanent" loss of graft patency

  4. Rate of change in Rutherford Category

    Time frame: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)

  5. Rate of change in Ankle-Brachial Index (ABI)

    Time frame: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Senior Manager, Clinical Affairs

CONTACT

[email protected]

+1 603 233 7685

Sponsors and collaborators

Lead sponsor

Atrium Medical Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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