Advanta VXT and Flixene PMCF Registry
ConditionPeripheral Arterial Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAtrium Medical Corporation
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
An approximate 1,000 patients from 25 sites across the US and Europe will participate in this registry. The number of patients and sites included will ensure a representation of the overall population, specifically in vascular surgery. No mandated procedures, assessments or visits will be implemented, given the non-interventional nature of the registry.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Advanta VXT Vascular Graft
DeviceThe 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
DeviceThe 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
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Peripheral Arterial Disease (PAD) Cohort2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants meeting Primary Efficacy Endpoint
Primary patency defined as freedom from graft occlusion or reintervention
Time frame
Procedure/surgery through registry completion (a minimum of 3 years)2
Percentage of Participants meeting Primary Safety Endpoint
Major Adverse Limb Events (MALE), defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis
Time frame
Procedure/surgery through registry completion (a minimum of 3 years)Secondary outcomes
1
Incidence of Reported Complications/Events
Time frame
Procedure/surgery through registry completion (a minimum of 3 years)2
Percentage of Participants meeting Primary-Assisted Graft Patency
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
Time frame
Procedure/surgery through registry completion (a minimum of 3 years)3
Percentage of Participants meeting Secondary Graft Patency
Defined as freedom from "permanent" loss of graft patency
Time frame
Procedure/surgery through registry completion (a minimum of 3 years)4
Rate of change in Rutherford Category
Time frame
Baseline, procedure/surgery, through registry completion (a minimum of 3 years)Sponsors and contacts
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Source ClinicalTrials.gov