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Advanta VXT and Flixene PMCF Registry

NCT ID: NCT07161583

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-25

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Peripheral Arterial Disease (PAD) Cohort

Advanta VXT Vascular Graft

Intervention Type 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

Intervention Type 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

Interventions

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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).

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atrium Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Director, Clinical Affairs

Role: STUDY_DIRECTOR

Getinge

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Senior Manager, Clinical Affairs

Role: CONTACT

Phone: +1 603 233 7685

Email: [email protected]

Facility Contacts

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Kaitlin Gossart

Role: primary

Other Identifiers

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DD021215-001

Identifier Type: -

Identifier Source: org_study_id