Status:
COMPLETED
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
Lead Sponsor:
Endologix
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararen...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01491945
Start Date
March 3 2013
End Date
August 1 2018
Last Update
October 15 2021
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35429
2
Arizona Heart Institute
Phoenix, Arizona, United States, 85016
3
John Muir Medical Center Concord, CA
Concord, California, United States, 94520
4
UCLA Medical Center
Los Angeles, California, United States, 90095