Advanta VXT and Flixene PMCF Registry

Not yet recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT07161583
• Lead Sponsor: Atrium Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-12
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants meeting Primary Efficacy Endpoint	Procedure/surgery through registry completion (a minimum of 3 years)	Primary patency defined as freedom from graft occlusion or reintervention
Percentage of Participants meeting Primary Safety Endpoint	Procedure/surgery through registry completion (a minimum of 3 years)	Major Adverse Limb Events (MALE), defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis

Secondary Outcome Measures

Name	Time	Method
Incidence of Reported Complications/Events	Procedure/surgery through registry completion (a minimum of 3 years)
Percentage of Participants meeting Primary-Assisted Graft Patency	Procedure/surgery through registry completion (a minimum of 3 years)	Defined as freedom from graft occlusion irrespective of whether an intervention was performed; in other words, primary-assisted patency is not lost when a reintervention is performed to preserve graft patency before occlusion occurs
Percentage of Participants meeting Secondary Graft Patency	Procedure/surgery through registry completion (a minimum of 3 years)	Defined as freedom from "permanent" loss of graft patency
Rate of change in Rutherford Category	Baseline, procedure/surgery, through registry completion (a minimum of 3 years)
Rate of change in Ankle-Brachial Index (ABI)	Baseline, procedure/surgery, through registry completion (a minimum of 3 years)