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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Senior Manager, Clinical Affairs
kristen.nolin@getinge.com
+1 603 233 7685
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2026-08
Participants
Target number of participants: 1000
Treatments
Peripheral Arterial Disease (PAD) Cohort
Related Therapeutic Areas
Sponsors
Leads: Atrium Medical Corporation