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

Endologix8 sites in 6 countries49 target enrollmentOctober 19, 2011

ConditionsAbdominal Aortic Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Abdominal Aortic Aneurysm
Sponsor: Endologix
Enrollment: 49
Locations: 8
Primary Endpoint: Primary Safety Endpoint
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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

Registry

clinicaltrials.gov

Start Date

October 19, 2011

End Date

March 20, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endologix

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Primary Safety Endpoint

Time Frame: 30 days

Major adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc

Secondary Outcomes

Mortality(Procedurally and to 5 Years)
Feasibility/Effectiveness(1 Year)
Stent Graft Patency(30 Days, 6 Months, and Years 1 to 5)
Major Adverse Events(>30 Days to 5 Years)
Number of Participants With Renal Dysfunction(30 Days, 6 Months and Years 1 to 5)
Aneurysm Rupture(Procedurally and to 5 Years)
Device Integrity(30 Days, 6 Months, and Years 1 to 5)
Aneurysm Diameter Change(6 Months, and Years 1 to 5)
Procedural/In-hospital Evaluations(Discharge)
Secondary Procedures(30 Days, 6 Month and Years 1 to 5)
Conversion to Open Repair(Procedurally and to 5 Years)