Actively Recruiting
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
Led by Atrium Medical Corporation · Updated on 2026-03-13
1000
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the long-term safety and performance of two types of vascular grafts, Advanta VXT and Flixene, used for repairing or replacing peripheral arteries. The study focuses on patients who have undergone these surgical procedures and seeks to provide more information about how useful these grafts are in clinical practice. Participants in this registry have received either the Advanta VXT graft, which has two layers including a support layer and sometimes a ringed design, or the Flixene graft, which has three layers and does not require ring support. The study involves collecting data from the time of the surgery and continuing for at least three years afterward to monitor outcomes. During the study, researchers will review medical records and follow-up information for a minimum of three years after the procedure. They will measure the percentage of participants meeting safety and efficacy goals, monitor complications, and assess graft performance using clinical indicators such as the Rutherford Category and Ankle-Brachial Index. This long-term follow-up helps to understand how well these vascular grafts work and their safety in real-world use.
CONDITIONS
Brief Title
Advanta VXT and Flixene PMCF Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide legally-effective written informed consent
- Male and female patients who have undergone repair or replacement of peripheral arteries with Advanta VXT or Flixene vascular graft
- At least 18 years old at the time of the procedure
- Available medical records with a minimum of 36 months of follow-up data
You will not qualify if you...
- Active infection in the area of graft placement at the time of graft implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day and up to hospital discharge
Participants undergo surgical repair or replacement of peripheral arteries using Advanta VXT or Flixene vascular grafts and receive immediate post-operative care.
1 surgical procedure visit and initial post-operative care visits
Duration - A minimum of 3 years
Participants are followed for safety and performance monitoring of the vascular grafts after surgery.
Regular follow-up visits over at least 3 years
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
CHU de Brest
Brest, Brittany Region, France
Actively Recruiting
Research Team
S
Senior Manager, Clinical Affairs
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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