Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

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Disease Information

Descriptive Information
Brief Title † Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
Official Title † 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
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
Study Phase Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Primary Safety Endpoint
Secondary Outcome Measure † Feasibility/effectiveness
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceEndovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 30
Start Date † November 2011
Completion Date May 2017
Primary Completion Date May 2012
Eligibility Criteria † Inclusion Criteria: - Adequate iliac/femoral access compatible with the required delivery systems - Non-aneurysmal infrarenal aortic neck = 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 =15mm, with diameter >=10 mm and 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 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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01348828
Organization ID CP-0003
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Endologix
Collaborators ††
Investigators † Principal Investigator: Daniel Clair, MD, The Cleveland Clinic
Information Provided By
Verification Date June 2013
First Received Date † May 3, 2011
Last Updated Date June 4, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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