Overview

This trial is active, not recruiting.

Conditions juxtarenal aortic aneurysm, pararenal aortic aneurysm
Treatment ventana fenestrated stent graft system
Phase phase 1
Sponsor Endologix
Start date November 2010
End date September 2011
Trial size 15 participants
Trial identifier NCT01437215, CP-0002

Summary

The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ventana fenestrated stent graft system
Endovascular repair of juxtarenal or pararenal aortic aneurysm

Primary Outcomes

Measure
Safety
time frame: 30 Days
Feasibility
time frame: 30 Days

Secondary Outcomes

Measure
Safety
time frame: >30 Days to 5 Years
Adverse Events
time frame: Procedurally to 5 Years
Distal Blood Flow
time frame: Discharge to 5 Years
Renal Dysfunction
time frame: Discharge to 5 Years
Device Performance
time frame: 30 Days to 5 Years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Informed consent understood and signed and pt agrees to all follow-up visits; - Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months - 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 at least 70mm - Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac; - Angle <60° (clock face) between the SMA and celiac artery - Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other - Iliac anatomy suitable for commercial bifurcated stent graft; - Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts Exclusion Criteria: - Life expectancy <1 year 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, dissecting, or mycotic aneurysm; - 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 or calcification of either renal artery; - 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 (female patient of childbearing potential only)

Additional Information

Official title Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Endologix.