An observational study in Complex Aortic Aneurysms, Thoracoabdominal Aneurysm and Fenestrated Endovascular Aortic Repair, sponsored by W.L.Gore & Associates. Not yet recruiting at 26 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by W.L.Gore & Associates · Observational
Austria, Denmark, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
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
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 400 is above the median of 150 across 117 observational studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are treated with aortic endografts designed exclusively with fenestrations for incorporation of the visceral arteries with at least one BXB device implanted
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
Patients who are treated with other endovascular techniques who required incorporation of BXB as bridging stent (i.e. PMEGs).
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: through 5-year follow-up
Survival
Freedom from all-cause mortality
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: through 5-year follow-up
Start is estimated for Dec 2026; primary completion for Dec 2031, 60 months later.
Of 44 observational studies under Aortic Aneurysm, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 107. This study's planned 60 months is below that.
How these figures are worked out, and which studies are left out of them.
Austria, Denmark, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Austria, Denmark, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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