Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

Study Overview
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Brief Summary
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The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

Detailed Description
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Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms. Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis. Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical repair; Type I endoleak after 30 days; Type III endoleak; clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.

Official Title
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Prospective, Multicenter, Single Arm Safety and Effectiveness Trial 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: Ventana Fenestrated Stent Graft System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 18 years old; Informed consent understood and signed and patient agrees to all follow-up visits; Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System: 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 ≥70mm SMA to aortoiliac bifurcation length ≥90mm; Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac; Angle ≤60° (clock face) between the SMA and CA Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation. The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm. Aortic diameter at the most caudal renal artery of 18 to 36mm 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 or myocardial infarction; Prior renal transplant; Length of either renal artery to be stented <13mm; Significant occlusive disease of either renal artery (>70% stenosis); An essential accessory renal artery; Indispensable inferior mesenteric artery; 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) Existing renal stent; Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)

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: Ventana Fenestrated Stent Graft System<br>Ventana Fenestrated Stent Graft System | Device: Ventana Fenestrated Stent Graft System<br>* The Ventana Fenestrated Stent Graft System consists of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts<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 at 30 Days | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc | 30 Days | 
| Effectiveness | Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. Procedural Technical Success is defined as a subject with successful implant. 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety- Number of Major Adverse Events > 30 Days to 5 Years | 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 | 
| Renal Dysfunction | Renal Dysfunction is calculated at greater than 30% reduction starting at baseline | Discharge to 5 Years | 
| Endoleaks | Endoleaks- Type IA, Type IB, Type II, Type IIIA, Type IIIB, Type IV, and Unknown Type 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). | 30 Days to 5 Years | 
| Clinical Utility Outcomes | Clinical Utility Outcomes consist of: fluoroscopy time, Bifurcated device placement time, Renal Artery Cannulation time, F-EVAR time and total procedure time. | At the time of the procedure | 
| Time in ICU | Number of days spent in the intensive care unit (ICU) | In-Hospital | 
| Time to Hospital Discharge | Number of days from the index procedure to discharge from the hospital. | Hospital Discharge (Post-Procedure) | 
| Device Patency | Device patency- Ventana & Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion | 30 Days to 5 Years | 
| Device Integrity | Device Integrity- Device Migration, Ventana Stent Fracture, Left Renal Stent Fracture, Right Renal Stent Fracture, and Stent Kinking/ Compression | 30 Days to 5 Years | 
| Aneurysm Sac Morphology | Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement | 30 Days to 5 Years | 
| Aneurysm Sac Diameter | Aneurysm Sac diameter changes | 30 Days to 5 Years | 
| Clinical Utility Outcomes | Clinical Utility Outcomes consists of: contrast volume and estimated blood loss. | At the time of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal aortic aneurysm, Renal stent, Juxtarenal, Pararenal, Endovascular