Advanta VXT and Flixene PMCF Registry
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.
| Condition(s) | Peripheral Arterial Disease |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Atrium Medical Corporation |
| Locations | Boston, Massachusetts, United States; Brest, Brittany Region, France |
| Start date | 2025-09-25 |
| NCT ID | NCT07161583 |
| Official listing | https://clinicaltrials.gov/study/NCT07161583 |