Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICEAdvanta 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).
DEVICEFlixene 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
Sponsors
Atrium Medical Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
France, United States
Contacts
CONTACTSenior Manager, Clinical Affairs
STUDY_DIRECTORDirector, Clinical Affairs
Getinge
Outcome results
None listed