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Advanta VXT and Flixene Grafts for Peripheral Arterial Disease

This registry is studying the long-term safety and performance of two medical devices, the Advanta VXT and Flixene vascular grafts. These grafts are used to repair or replace arteries in the legs and arms (peripheral arteries) in people with Peripheral Arterial Disease. The study aims to see how well these grafts work and how safe they are over time. You may be able to join if you are at least 18 years old and have already had a procedure using one of these grafts. The study will track how many participants meet certain safety and effectiveness goals over at least three years. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 1000 participants.
What's involved
You would need to have had a procedure using the Advanta VXT or Flixene vascular graft and have records available for data collection for at least 36 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the time of their procedure/surgery through at least three years after the procedure.

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NCT07161583

Advanta VXT and Flixene PMCF Registry

Recruiting
Not specifiedAges 18+Observational
Atrium Medical Corporation
~1,000 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Advanta VXT Vascular GraftFlixene Vascular Graft

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants meeting Primary Efficacy Endpoint
Measured over Procedure/surgery through registry completion (a minimum of 3 years)
+1 more outcome measured

Conditions

Peripheral Arterial Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

2 sites across 2 states
Massachusetts1
Brittany Region1

Study leadership

  • Director, Clinical Affairs · STUDY_DIRECTOR · Getinge

Who to contact

Senior Manager, Clinical Affairs
[email protected]
+1 603 233 7685
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Percentage of Participants meeting Primary Efficacy EndpointProcedure/surgery through registry completion (a minimum of 3 years)

    Primary patency defined as freedom from graft occlusion or reintervention

  • Percentage of Participants meeting Primary Safety EndpointProcedure/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