Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

Study Overview
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Brief Summary
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The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

Detailed Description
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The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below: Endologix unibody bifurcated stent graft Endologix fenestrated proximal extension stent graft Endologix renal stent graft

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 >= 70 SMA to aortoiliac bifurcation length >=90mm Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length >=15mm and angle <=60° to the aneurysm sac Angle <=60° (clock face) between the SMA and CA Renal arteries both at or below the SMA by <=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other Common iliac artery distal fixation site with: distal fixation length >=15mm, with diameter >=10 mm and <=23 mm and angle <=90° to the aortic bifurcation Ability to preserve at least one hypogastric artery Exclusion Criteria: Life expectancy <2 years 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, or mycotic aneurysm Aortic dissection 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 Recent(within prior three months)myocardial infarction Prior renal transplant Length of either renal artery to be stented <12mm Significant occlusive disease or calcification of either renal artery (>70%) 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

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 |
| --- | --- |
| Other: Single Arm<br>All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed. | Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)<br>* Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System<br>* Other names: Xpand;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Major adverse events defined as: All-cause death Bowel ischemia Myocardial infarction Paraplegia Renal failure Respiratory failure Stroke Blood loss >=1,000cc | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility/Effectiveness | Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak Procedural Technical Success is defined as a subject with successful implant. Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery). | 1 Year | 
| Procedural/In-hospital Evaluations | Fluoroscopy time, Renal Artery Cannulation time and procedure time | Procedurally and to hospital discharge | 
| Mortality | All-cause and aneurysm-related | Procedurally and to 5 Years | 
| Major Adverse Events | All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc | >30 Days to 5 Years | 
| Number of Participants With Renal Dysfunction | Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR>=60 and Renal Dysfunction In subjects with baseline eGFR <60 | 30 Days, 6 Months and Years 1 to 5 | 
| Aneurysm Rupture | Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure | Procedurally and to 5 Years | 
| Conversion to Open Repair | Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason | Procedurally and to 5 Years | 
| Device Integrity | Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression | 30 Days, 6 Months, and Years 1 to 5 | 
| Stent Graft Patency | Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion | 30 Days, 6 Months, and Years 1 to 5 | 
| Aneurysm Diameter Change | Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth. | 6 Months, and Years 1 to 5 | 
| Secondary Procedures | Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect. | 30 Days, 6 Month and Years 1 to 5 | 
| Procedural/In-hospital Evaluations | Contrast volume and estimated blood loss | Procedurally and to hospital discharge | 
| Procedural/In-hospital Evaluations | Time to hospital discharge | Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal, Abdominal Aortic Aneurysm, Fenestrated, Renal Stent, Juxtarenal, Pararenal, Endologix