Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Study Overview
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Brief Summary
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The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system for the treatment of aortic aneurysms.

Detailed Description
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Study Update as of 2/20/2023;159 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.

Official Title
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Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Conditions
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Thoracoabdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Zenith® t-Branch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The patient must have one of the following: Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or Penetrating ulcers: ≥20mm in depth or Chronic type B aortic dissections: ≥50mm total aortic diameter or Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size. Additional criteria for LP material • Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator Exclusion Criteria General Criteria Life-expectancy less than 12 months Refusal to receive blood products Age <18 years Pregnant or breastfeeding or planning on becoming pregnant within 60 months Unwilling to comply with the follow-up schedule Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized Medical Criteria Uncontrolled systemic infection Untreatable malignancy Uncontrollable anaphylaxis to iodinated contrast Known allergy(ies) to device materials Anatomic Criteria Any pathology of mycotic origin Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial) Inability to insert the Zenith® t-Branch device through iliofemoral approach Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm Proximal landing zone length <25mm to allow secure fixation and seal Proximal landing zone diameter of <24mm or >42mm Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible subjects will receive treatment with the investigational t-Branch Endovascular Graft
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Treatment Arm<br>All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft. | Device: Zenith® t-Branch<br>* The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Mortality | The primary aim of this study is to determine the rate of early mortality after branch endograft treatment. | 30 days post implant of the branch endografts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Neurologic Complications/Late Branch Vessel Patency | The secondary aims of this study are to determine the rates of neurologic complications and late branch vessel patency after branch endograft treatment, and the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms | Day 0-Day 30 (Early) Day 31-1825 (Late) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Aneurysms