Following people who receive vascular grafts for peripheral arterial disease
Follows how Advanta VXT and Flixene grafts perform in people having artery surgery.
Key facts
- Who runs it
- Atrium Medical Corporation
- Where
- Boston, United StatesSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- Advanta VXT and Flixene PMCF Registry
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 25 Sept 2025
- Expected to end
- Dec 2027
- Type of study
- Observational
- Treatments tested
- Advanta VXT Vascular Graft
- Flixene Vascular Graft
- Record updated
- 11 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who already had surgery to repair or replace leg or other peripheral arteries using the Advanta VXT or Flixene vascular graft. It collects long-term data from their records.
- Age
- 18 years or older at the time of the procedure.
- Sex
- Men and women can join.
- Disease stage
- Peripheral arterial disease treated by surgical repair or replacement of the peripheral arteries.
- Earlier treatment
- People must have had repair or replacement of the peripheral arteries with the Advanta VXT or Flixene vascular graft. Records must cover at least 36 months of follow-up.
Main reasons for not taking part
- Active infection in the area where the graft was placed, at the time it was implanted
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft
Where in United States
Also in 1 other country, 1 site
- Massachusetts General HospitalBoston, United StatesContact: Kaitlin GossartTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Peripheral Arterial Disease (PAD) Cohort
Treatment: Advanta VXT Vascular Graft and Flixene Vascular Graft
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Following people who receive vascular grafts for peripheral arterial diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 11 September 2026