Advanta VXT and Flixene PMCF Registry

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Atrium Medical Corporation
Study ID
NCT07161583
Status
Recruiting
Apply to this trial

Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Advanta VXT Vascular Graft — DEVICE
    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 — DEVICE
    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

Study Details

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.

Key Dates

Start date
Sep 25, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Peripheral Arterial Disease (PAD) Cohort

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Kaitlin Gossart
[email protected]
617-726-9609
Anahita Dua (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies