Zenith® Fenestrated+ Clinical Study

Study Overview
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Brief Summary
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The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

Official Title
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Zenith® Fenestrated+ Endovascular Graft Clinical Study

Conditions
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Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm

Intervention / Treatment
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* Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System


Participation Criteria
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Eligibility Criteria
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Include Criteria: Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator Exclusion Criteria: Age < 18 years Life expectancy < 2 years Pregnant, breast-feeding, or planning to become pregnant within 60 months Inability or refusal to give informed consent by the patient or legally authorized representative Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aortic abdominal aneurysm<br> | Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System<br>* Endovascular aneurysm repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of device technical success and procedural safety | Percent of patients with device technical success and freedom from procedural safety events in the following criteria: Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke | 30 days post procedure | 
| Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention | Percent of patients meeting the following criteria: Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency) | 12 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovascular, Vascular Diseases, Cardiovascular Diseases, Fenestration