Abdominal Aorta Aneurism, Chronic Dissection, Complex Aortic Aneurysms, Endovascular Aortic Repair, Fenestrated Endovascular Aortic Repair, Thoracoabdominal Aneurysm
Conditions
Keywords
FEVAR, BEVAR, TAAA, AAA, Visceral, aortic aneurysm, PMEGs
Brief summary
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
Detailed description
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
Interventions
None listed
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed Consent Form (ICF) is signed by Subject. 2. Age ≥ 18 years at time of informed consent signature. 3. Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair. 4. Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated). 5. Patient is willing to adhere to the institutional standard of care follow-up.
Exclusion criteria
1. Patient has a prior visceral artery stenting not associated with registry procedure. 2. Patient treated for acute or sub-acute dissection, \<90 days from onset of symptoms 3. Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique. 4. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 5. Patient has known coagulation disorders including hypercoagulability that are not amenable to treatment. 6. Patient has a life expectancy \< 1-year. 7. Patient is participating in an investigational study which may confound registry results, unless approved by Gore
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Target Vessel Instability | through 1 year Follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Technical Success | At procedure | Successful catheterization and stent placement in all intended target vessels. |
| Procedural Technical Success | at procedure | 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. |
| Clinical Success | through 5-year follow-up | 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 |
| Major Adverse Events | through 5-year follow-up | 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 Aneurysm-Related Mortality | through 5-year follow-up | 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 Target Vessel Instability through 5-year follow-up | through 5-year follow-up | 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 |
| Primary Patency | through 5-year follow-up | 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. |
| Freedom from Reintervention | through 5-year follow-up | 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. |
| Survival | through 5-year follow-up | Freedom from all-cause mortality |
| Aneurysm sac changes | through 5-year follow-up | 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. |
| Primary Assisted Patency | through 5-year follow-up | Number of patients with endovascular intervention performed to maintain patency in the presence of a stenosis before occlusion |
| Secondary Patency | through 5-year follow-up | Number of patients with endovascular restoration of patency after occlusion of the side branch, stent, or stent graft has already occurred. |
Outcome results
None listed