Pilot Study of the Endologix Fenestrated Stent Graft System

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.

Official Title
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Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms

Conditions
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Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm

Intervention / Treatment
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* Device: Ventana Fenestrated Stent Graft System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent understood and signed and pt agrees to all follow-up visits; Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months Adequate iliac/femoral access compatible with the required delivery systems Non-aneurysmal infrarenal aortic neck <15mm in length Most caudal renal artery to aortoiliac bifurcation length at least 70mm Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac; Angle <60° (clock face) between the SMA and celiac artery Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other Iliac anatomy suitable for commercial bifurcated stent graft; Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts Exclusion Criteria: Life expectancy <1 year as judged by the investigator; Psychiatric or other condition that may interfere with the study; Participating in the enrollment or 30-day follow-up phase of another clinical study; Known allergy to any device component; Coagulopathy or uncontrolled bleeding disorder; Contraindication to contrast media or anticoagulants; Ruptured, leaking, dissecting, or mycotic aneurysm; Serum creatinine (S-Cr) level >2.0 mg/dL; Traumatic vascular injury; Active systemic or localized groin infection; Connective tissue disease (e.g., Marfan's Syndrome); Recent (within prior three months) cerebrovascular accident or myocardial infarction; Prior renal transplant; Length of either renal artery to be stented <13mm; Significant occlusive disease or calcification of either renal artery; An essential accessory renal artery; Indispensable inferior mesenteric artery; Untreated aneurysmal disease of the descending thoracic aorta; Clinically significant mural thrombus circumferentially in the suprarenal segment; Prior iliac artery stent implanted that may interfere with delivery system introduction; Unsuitable vascular anatomy Pregnancy (female patient of childbearing potential only)

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: Fenestrated Endografting<br> | Device: Ventana Fenestrated Stent Graft System<br>* Endovascular repair of juxtarenal or pararenal aortic aneurysm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Number of Major Adverse Events (MAEs) | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc | 30 Days | 
| Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration | Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Number of Major Adverse Events (MAEs) | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc | >30 Days to 5 Years | 
| Adverse Events | All adverse events, whether serious or non-serious | Procedurally to 5 Years | 
| Distal Blood Flow | Ankle-brachial index measurements | Discharge to 5 Years | 
| Renal Dysfunction | eGFR reduction >30% from baseline | Discharge to 5 Years | 
| Device Performance | Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology | 30 Days to 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysm, renal stent, juxtarenal, pararenal