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Recruiting
NCT07161583
Advanta VXT and Flixene PMCF Registry
Conditions: Peripheral Arterial Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Atrium Medical Corporation
Location: Massachusetts General Hospital Boston Massachusetts
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 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
Source: ClinicalTrials.gov (NCT07161583). StuddyBuddy aggregates publicly available trial information.
