Real-World Data Collection of the GORE Devices When Used in the Treatment of Aortic Pathologies Which Requires the Incorporation of the Visceral Arteries.

N/ANot Yet RecruitingNCT07480395

W.L.Gore & Associates400 enrolled

Overview

The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion

Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Complex Aortic Aneurysms Thoracoabdominal Aneurysm Fenestrated Endovascular Aortic Repair Endovascular Aortic Repair Abdominal Aorta Aneurism

Eligibility

Outcomes

Primary Outcomes

Freedom from Target Vessel Instability

Freedom from any death or rupture related to side branch complication (e.g., endoleaks, rupture); any branch occlusion; or any secondary intervention indicated to treat a branch-related complication, including endoleaks, disconnection, kink, stenosis, occlusion, or rupture

Time frame: through 1 year Follow-up

Secondary Outcomes

Target Vessel Technical Success

Successful catheterization and stent placement in all intended target vessels.

Time frame: At procedure

Procedural Technical Success

All of the qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleak, branch occlusion, or graft limb obstruction): * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits at index procedure. * Successful delivery and deployment of the aortic stent graft and all modular stent graft components at index procedure * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels at final completion angiography * Absence of type I or type III endoleaks at final completion angiography that extends beyond 30 days by confirmatory imaging * Patency of all aortic modular stent graft components and intended side branch components at final completion angiography.

Time frame: at procedure

Clinical Success

Requires all of the following to be met: * Procedural Technical success * Absence of death from the initial procedure, secondary intervention, or aorta-related cause * Absence of persistent type I or type III endoleaks * Absence of aneurysm sac expansion \> 5mm * Absence of device migration \> 10mm * Absence of failure due to device integrity issues * Absence of aneurysm rupture * Absence of conversion to open surgical repair * Absence of permanent paraplegia o Note: defined as spinal cord deficit with inability to walk and not resolving at a future assessment * Absence of disabling stroke o Note: defined as stroke with one of the following: complete hemianopia, severe aphasia, visual or sensory extinction, or any weakness limiting sustained effort against gravity * Absence of new-onset dialysis following the initial operation