Advanta VXT and Flixene PMCF Registry

Atrium Medical

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Flixene Vascular Graft; Device: Advanta VXT Vascular Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT07161583

DD021215-001

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Peripheral Arterial Disease (PAD) Cohort

Treatment:

Device: Advanta VXT Vascular Graft

Device: Flixene Vascular Graft