Advanta VXT and Flixene PMCF Registry

NCT07161583 | Recruiting FDA Device

• 1 other identifier: DD021215-001
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants meeting Primary Efficacy Endpoint

  Primary patency defined as freedom from graft occlusion or reintervention

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

• 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

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

Secondary Outcomes (5)

• Incidence of Reported Complications/Events

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

• Percentage of Participants meeting Primary-Assisted Graft Patency

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

• Percentage of Participants meeting Secondary Graft Patency

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

• Rate of change in Rutherford Category

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

• Rate of change in Ankle-Brachial Index (ABI)

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

Study Arms (1)

Peripheral Arterial Disease (PAD) Cohort

Device: Advanta VXT Vascular Graft; Device: Flixene Vascular Graft

Interventions

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).

Peripheral Arterial Disease (PAD) Cohort

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

Peripheral Arterial Disease (PAD) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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

Sponsors & Collaborators

• Atrium Medical Corporation: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

CHU de Brest

Brest, Brittany Region, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Director, Clinical Affairs

  Getinge

  STUDY DIRECTOR

Central Study Contacts

Senior Manager, Clinical Affairs

CONTACT

+1 603 233 7685; kristen.nolin@getinge.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 8, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (1)