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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
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- Advanta VXT Vascular Graft (device)
- Flixene Vascular Graft (device)
Sponsor: Atrium Medical Corporation · Participants: 1,000 · Started: Sep 25, 2025
Contact the study team
- Senior Manager, Clinical Affairs · Phone: +1 603 233 7685
Official record on ClinicalTrials.gov — NCT07161583
Locations in the U.S.
| Massachusetts | Massachusetts General Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.