Status:
RECRUITING
Advanta VXT and Flixene PMCF Registry
Lead Sponsor:
Atrium Medical Corporation
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
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 inten...
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.
Exclusion
- \- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft
Key Trial Info
Start Date :
September 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07161583
Start Date
September 25 2025
End Date
August 1 2026
Last Update
November 13 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114