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Advanta VXT and Flixene PMCF Registry | Clinical Trials | Clareo Health

RECRUITING

Advanta VXT and Flixene PMCF Registry

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

NCT07161583•Atrium Medical Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

CHU de Brest

Brest, Brittany Region, France

Key Dates

Start Date

September 25, 2025

Primary Completion Date

September 1, 2026

Completion Date

October 1, 2026

Last Updated

March 13, 2026

Enrollment

1,000

ESTIMATED participants

Conditions

Peripheral Arterial Disease

Interventions

Advanta VXT Vascular Graft

DEVICE

Flixene Vascular Graft

DEVICE

Contacts

Senior Manager, Clinical Affairs

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Advanta VXT and Flixene PMCF Registry

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

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