Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries

Study Overview
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Brief Summary
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Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.

Detailed Description
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Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries. The registry procedures consist of two phases, retrospective phase and prospective phase. The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature). The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.

Official Title
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Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries

Conditions
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Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm

Intervention / Treatment
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* Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017 Age ≥18 years at the time of implant Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations. Exclusion Criteria: Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms Patient treated using physician-modified endovascular grafts Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment Patient was pregnant at the time of treatment. Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints. Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fEVAR<br>Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair | Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis<br>* Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent<br>|
| bEVAR<br>Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair | Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis<br>* Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent<br>|
| fEVAR and bEVAR<br>Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair | Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis<br>* Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel patency (patient level) | Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintervention (total and reintervention that can be attributed to branches originally treated with the VBX Stent Graft) | Any repeated vascular or nonvascular procedure related to the index procedure | 12 months and annually through 5 years post-implant | 
| Target Vessel Technical Success | Successful catheterization and VBX Stent Graft placement in all intended target vessels | at the procedure | 
| Primary Technical Success (Total Endovascular Procedure) | A modified technical success definition, requiring the following: Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels Patency of all aortic modular stent graft components and intended side branch components Absence of type I or type III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography [MRA], or duplex ultrasound) | at the procedure | 
| Target vessel instability | Death or rupture related to side branch complication (e.g., endoleak) or reintervention to treat a branch-related complication, including endoleak, disconnection, kink, stenosis, occlusion, or rupture | 12 months and annually through 5 years post-implant | 
| Target vessel patency (patient level) | Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. | annually from 2-5 years post-implant | 
| Target vessel patency (vessel level analysis) | Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. | annually from procedure to 5 years post-implant | 
| Aneurysm-related mortality | Any death that occurs within the first 30 days or any death that results from aneurysm rupture, aorta-related complications (eg, infection, occlusion, dissection, hematoma), or a complication of a secondary intervention | at 12 months and annually through 5 years post-implant | 
| MAEs at 30 days | MAEs according to stardard definition. | 30 days post implant |