Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.

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

Successful catheterization and stent placement in all intended target vessels.

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.

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

Any of the following events:

• All-cause mortality
• Myocardial infarction (MI): MI resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome
• Respiratory failure requiring prolonged (> 24 hours from anticipated) mechanical ventilation or reintubation
• Renal function decline characterized by one or more of the following:

• >50% reduction in baseline estimated glomerular filtration rate (eGFR); or,
• New-onset dialysis
• Bowel ischemia requiring surgical resection or not resolving with medical therapy
• Permanent paraplegia
• Major stroke.

• Note: any stroke that is disabling or fatal

Freedom from all the following:

• Any death that occurs within the first 30 days
• any death that results from aneurysm rupture, aorta-related complications such as infection, occlusion, dissection, hematoma, or
• any death that results from a complication of a secondary intervention

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

Uninterrupted patency with no occlusion or additional procedures performed intended to maintain patency of the stent or native target vessel.

Note: Interventions intended to treat endoleaks or stent disconnection do not count as loss of primary patency.

Any repeated vascular or nonvascular procedure on the aortic endovascular stent graft, its branches, or any other stent graft placed in combination with these devices during the index procedure.

Freedom from all-cause mortality

Aneurysm Enlargement: An increase in maximum aorta diameter of > 5mm in the region encompassed by the initial aneurysm as compared to baseline.

Aneurysm Shrinkage: A decrease in aorta diameter of > 5-mm in the region encompassed by the initial aneurysm as compared to baseline.

Stable Aneurysm: A ≤ 5 millimeter (mm) change in aorta diameter in the region encompassed by the initial aneurysm as compared to baseline.

Number of patients with endovascular intervention performed to maintain patency in the presence of a stenosis before occlusion

Number of patients with endovascular restoration of patency after occlusion of the side branch, stent, or stent graft has already occurred.