Advanta VXT and Flixene PMCF Registry
Sponsored by Atrium Medical Corporation
About this trial
Last updated a month ago
Study ID
DD021215-001
Status
Recruiting
Type
Observational
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Started 7 months ago
What is this trial 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.
What are the participation requirements?
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