NCT01437215CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Endologix
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Safety - Number of Major Adverse Events (MAEs)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Fenestrated Endografting
Experimental
Intervention: Ventana Fenestrated Stent Graft System (Device)
Outcomes
Primary Outcomes
Safety - Number of Major Adverse Events (MAEs)
Time Frame: 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration
Time Frame: 30 Days
Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
Secondary Outcomes
- Adverse Events(Procedurally to 5 Years)
- Renal Dysfunction(Discharge to 5 Years)
- Safety - Number of Major Adverse Events (MAEs)(>30 Days to 5 Years)
- Distal Blood Flow(Discharge to 5 Years)
- Device Performance(30 Days to 5 Years)
Investigators
Study Sites (2)
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