Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysm
Treatment ventana fenestrated stent graft system
Phase phase 2
Sponsor Endologix
Start date March 2012
End date March 2016
Trial size 122 participants
Trial identifier NCT01491945, CP-0004

Summary

The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective 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
Arm
(Experimental)
ventana fenestrated stent graft system
The Ventana Fenestrated Stent Graft System consists of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts

Primary Outcomes

Measure
Safety
time frame: 30 Days
Effectiveness
time frame: 1 Year

Secondary Outcomes

Measure
Safety
time frame: >30 Days 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
Clinical Utility Outcomes
time frame: At the time of the procedure
Time in ICU
time frame: In-Hospital
Time to Hospital Discharge
time frame: Hospital Discharge (Post-Procedure)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female at least 18 years old; - Informed consent understood and signed and patient agrees to all follow-up visits; - Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter - Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System: - 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 ≥70mm - SMA to aortoiliac bifurcation length ≥90mm; - Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac; - Angle ≤60° (clock face) between the SMA and CA - Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation. - The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm. - Aortic diameter at the most caudal renal artery of 18 to 36mm 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 or myocardial infarction; - Prior renal transplant; - Length of either renal artery to be stented <13mm; - Significant occlusive disease of either renal artery (>70% stenosis); - An essential accessory renal artery; - Indispensable inferior mesenteric artery; - 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) - Existing renal stent; - Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)

Additional Information

Official title Prospective, Multicenter, Single Arm Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
Principal investigator Daniel G Clair, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Endologix.