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.
The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below: 1. Endologix unibody bifurcated stent graft 2. Endologix fenestrated proximal extension stent graft 3. Endologix renal stent graft
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
UCLA
Los Angeles, California, United States
University of Indiana
Indianapolis, Indiana, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital Universidad Catolica
Santiago, Chile
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
Time frame: 30 days
Feasibility/Effectiveness
Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak. 1. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak 2. Procedural Technical Success is defined as a subject with successful implant. 3. 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. 4. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 5. 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). 6. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Time frame: 1 Year
Procedural/In-hospital Evaluations
Fluoroscopy time, Renal Artery Cannulation time and procedure time
Time frame: Procedurally and to hospital discharge
Mortality
All-cause and aneurysm-related
Time frame: 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
Time frame: >30 Days to 5 Years
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Bureau de Recherche Clinique
Créteil, France
Rijnstate Hospital
Arnhem, Netherlands
Auckland City Hospital
Auckland, New Zealand
St. George's Vascular Institute
London, United Kingdom
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
Time frame: 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
Time frame: 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
Time frame: Procedurally and to 5 Years
Device Integrity
Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 30 Days, 6 Month and Years 1 to 5
Procedural/In-hospital Evaluations
Contrast volume and estimated blood loss
Time frame: Procedurally and to hospital discharge
Procedural/In-hospital Evaluations
Time to hospital discharge
Time frame: Discharge