Long-term follow-up of Advanta VXT and Flixene vascular grafts
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
Atrium Medical Corporation · NCT07161583
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Atrium Medical Corporation (industry) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT07161583 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease