Long-term follow-up of Advanta VXT and Flixene vascular grafts
Official title: 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
Run by Atrium Medical Corporation · NCT07161583 · Data updated 2026-11-12
This registry will track how well Advanta VXT and Flixene vascular grafts work and how safe they are in adults who received them for peripheral arterial disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Atrium Medical Corporation Industry-sponsored |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | September 25, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07161583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) who previously had peripheral artery repair or replacement using an Advanta VXT or Flixene vascular graft, can provide informed consent, and have at least 36 months of available follow-up records are ideal candidates.
✕Probably not a fit
Patients who did not receive an Advanta VXT or Flixene graft, those with active infection at the graft site at implantation, or those without sufficient follow-up records are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non-interventional, observational registry collecting existing clinical records from adults who underwent peripheral artery repair or replacement with Advanta VXT or Flixene grafts. Participating sites will provide a minimum of 36 months of follow-up data on safety and device performance. No changes to clinical care are mandated — data are collected from routine visits, imaging, and medical records. The registry is sponsored by Atrium Medical Corporation and enrolls patients at participating centers including Massachusetts General Hospital and CHU de Brest.
Why it matters
Potential benefit: If successful, the registry could improve understanding of long-term graft safety and performance and help clinicians choose the best graft for patients with peripheral arterial disease.
How similar studies have gone: Post‑market registries and observational reports for comparable ePTFE vascular grafts have reported acceptable mid-term outcomes, but comprehensive long-term multicenter registry data remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
CHU de Brest
Brest, Brittany Region, France Recruiting
Study contacts
- Study coordinator: Senior Manager, Clinical Affairs
- Email: kristen.nolin@getinge.com
- Phone: +1 603 233 7685
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.