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Recruiting NCT07161583

Advanta VXT and Flixene PMCF Registry

— Observational Peripheral Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Advanta VXT Vascular Graft, Flixene Vascular Graft.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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
  • 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

Primary outcome measures

  • Percentage of Participants meeting Primary Efficacy Endpoint [Time frame: Procedure/surgery through registry completion (a minimum of 3 years)]
  • Percentage of Participants meeting Primary Safety Endpoint [Time frame: Procedure/surgery through registry completion (a minimum of 3 years)]
Secondary outcome measures (5)
  • Incidence of Reported Complications/Events [Time frame: Procedure/surgery through registry completion (a minimum of 3 years)]
  • Percentage of Participants meeting Primary-Assisted Graft Patency [Time frame: Procedure/surgery through registry completion (a minimum of 3 years)]
  • Percentage of Participants meeting Secondary Graft Patency [Time frame: Procedure/surgery through registry completion (a minimum of 3 years)]
  • Rate of change in Rutherford Category [Time frame: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)]
  • Rate of change in Ankle-Brachial Index (ABI) [Time frame: Baseline, procedure/surgery, through registry completion (a minimum of 3 years)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston
France · 1 center
  • CHU de Brest — Brest

Identifiers

NCT: NCT07161583 · DD021215-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗