This trial is active, not recruiting.

Condition abdominal aortic aneurysm
Treatment endovascular aortic aneurysm repair (endologix fenestrated stent graft system)
Phase phase 2
Sponsor Endologix
Start date November 2011
End date May 2012
Trial size 30 participants
Trial identifier NCT01348828, CP-0003


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Primary Safety Endpoint
time frame: 30 days

Secondary Outcomes

time frame: 30 Days
Procedural/in-hospital evaluations
time frame: Procedurally and to hospital discharge
time frame: Procedurally and to 5 Years
Major Adverse Events
time frame: >30 Days to 5 Years
Adverse Events
time frame: Procedurally and to 5 Years
Renal Dysfunction
time frame: 30 Days, 6 Months and Years 1 to 5
Aneurysm Rupture
time frame: Procedurally and to 5 Years
Conversion to Open Repair
time frame: Procedurally and to 5 Years
Distal Blood Flow
time frame: Pre-discharge, 30 Days, 6 Months, and Years 1 to 5
Renal Stent Graft Patency and Integrity
time frame: 30 Days, 6 Months, and Years 1 to 5
Stent Graft Patency and Integrity
time frame: 30 Days, 6 Months, and Years 1 to 5
Endograft Performance
time frame: 30 Days, 6 Months, and Years 1 to 5
Secondary Procedures
time frame: 30 Days, 6 Months, and Years 1 to 5

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Daniel Clair, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Endologix.