RecruitingNCT07161583

Advanta VXT and Flixene PMCF Registry

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

Sponsor

Atrium Medical Corporation

Enrollment

1,000 participants

Start Date

Sep 25, 2025

Study Type

OBSERVATIONAL

Conditions

Peripheral Arterial Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria1

\- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft

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Interventions

DEVICEAdvanta 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).

DEVICEFlixene 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