Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System (NCT01491945) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
United States76 participantsStarted 2013-03-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…