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

The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracoabdominal Aneurysm; Endovascular Aortic Repair; Complex Aortic Aneurysms; Abdominal Aorta Aneurism; Fenestrated Endovascular Aortic Repair; Chronic Dissection

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

• Study Type: Observational
• Enrollment (Estimated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
FEVAR; Patients who are treated with aortic endografts designed exclusively with fenestrations for incorporation of the visceral arteries with at least one BXB device implanted
BEVAR; Patients who are treated with aortic endografts designed exclusively with directional branches for incorporation of the visceral arteries with at least one BXB device implanted
OTHER; Patients who are treated with other endovascular techniques who required incorporation of BXB as bridging stent (i.e. PMEGs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through 1 year Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Vessel Technical Success	Successful catheterization and stent placement in all intended target vessels.	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.	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 paraplegiao Note: defined as spinal cord deficit with inability to walk and not resolving at a future assessment; Absence of disabling strokeo 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	through 5-year follow-up
Freedom from Aneurysm-Related Mortality	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	through 5-year follow-up
Freedom from Target Vessel Instability 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	through 5-year follow-up
Primary Patency	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.	through 5-year follow-up
Freedom from Reintervention	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.	through 5-year follow-up
Survival	Freedom from all-cause mortality	through 5-year follow-up
Aneurysm sac changes	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.	through 5-year follow-up
Major Adverse Events	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	through 5-year follow-up
Primary Assisted Patency	Number of patients with endovascular intervention performed to maintain patency in the presence of a stenosis before occlusion	through 5-year follow-up
Secondary Patency	Number of patients with endovascular restoration of patency after occlusion of the side branch, stent, or stent graft has already occurred.	through 5-year follow-up

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: aortic aneurysm; AAA; Visceral; TAAA; BEVAR; FEVAR; PMEGs
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: VSC 25-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No