Advanta VXT and Flixene PMCF Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

Advanta VXT Vascular Graft: The Advanta VXT graft is a two (2)-layer graft employing a single layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. Some Advanta VXT configurations include Helix, which is a monofilament bead wrapped circumferentially around a portion or the entire length of the graft (such a graft is also called a Ringed Graft). The helix rings are bonded to the exterior surface of the graft. Advanta VXT Tapers are formed by changing the graft diameter, expanding from a small Inner Diameter (ID) to a larger ID (with the result that one end is larger).

Flixene Vascular Graft: The Flixene vascular graft is a three (3)-layered graft comprised of ePTFE. The Flixene graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary

Study 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

Primary outcome measure(s)

• 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

Trial sites (2)

Other trials for the same condition