Recruiting

Advanta VXT & Flixene

Sponsor:

Atrium Medical Corporation

Code:

NCT07161583

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Advanta VXT Vascular Graft

Flixene Vascular Graft

Study Details

Brief 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.

Conditions

Peripheral Arterial Disease

Study ID

NCT07161583

Start date

Sep 25, 2025

Status verified date

Mar, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Peripheral Arterial Disease (PAD) Cohort

Interventions

Advanta VXT Vascular Graft

The Advanta VXT graft is a two (2)-layer graft employing a single layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. Some Advanta VXT configurations include Helix, which is a monofilament bead wrapped circumferentially around a portion or the entire length of the graft (such a graft is also called a Ringed Graft). The helix rings are bonded to the exterior surface of the graft. Advanta VXT Tapers are formed by changing the graft diameter, expanding from a small Inner Diameter (ID) to a larger ID (with the result that one end is larger).

Flixene Vascular Graft

The Flixene vascular graft is a three (3)-layered graft comprised of ePTFE. The Flixene graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary

Primary outcome measure

  • Percentage of Participants meeting Primary Efficacy Endpoint [ Time Frame: Procedure/surgery through registry completion (a minimum of 3 years) ]
  • Percentage of Participants meeting Primary Safety Endpoint [ Time Frame: Procedure/surgery through registry completion (a minimum of 3 years) ]

Central Contacts and Locations

Central contacts

Senior Manager, Clinical Affairs

+1 603 233 7685kristen.nolin@getinge.com

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kaitlin Gossart

617-726-9609kgossart@mgh.harvard.edu

Principal Investigator:

Anahita Dua

More Information

Sponsor

Atrium Medical Corporation

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atrium Medical Corporation on 2026-03-13.