NCT01348828CompletedNot Applicable
Prospective, Multicenter, Single Arm Feasibility and 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
- 49
- Locations
- 8
- Primary Endpoint
- Primary Safety Endpoint
Study Overview
Brief Summary
The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Detailed Description
The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:
- Endologix unibody bifurcated stent graft
- Endologix fenestrated proximal extension stent graft
- Endologix renal stent graft
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
- •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 >= 70
- •SMA to aortoiliac bifurcation length >=90mm
- •Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length >=15mm and angle <=60° to the aneurysm sac
- •Angle <=60° (clock face) between the SMA and CA
- •Renal arteries both at or below the SMA by <=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
- •Common iliac artery distal fixation site with: distal fixation length >=15mm, with diameter >=10 mm and <=23 mm and angle <=90° to the aortic bifurcation
- •Ability to preserve at least one hypogastric artery
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
- •Recent(within prior three months)myocardial infarction
- •Prior renal transplant
- •Length of either renal artery to be stented <12mm
- •Significant occlusive disease or calcification of either renal artery (>70%)
- •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
Arms & Interventions
Single Arm
Other
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.
Intervention: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System) (Device)
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 30 days
Major adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc
Secondary Outcomes
- Mortality(Procedurally and to 5 Years)
- Feasibility/Effectiveness(1 Year)
- Stent Graft Patency(30 Days, 6 Months, and Years 1 to 5)
- Major Adverse Events(>30 Days to 5 Years)
- Number of Participants With Renal Dysfunction(30 Days, 6 Months and Years 1 to 5)
- Aneurysm Rupture(Procedurally and to 5 Years)
- Device Integrity(30 Days, 6 Months, and Years 1 to 5)
- Aneurysm Diameter Change(6 Months, and Years 1 to 5)
- Procedural/In-hospital Evaluations(Discharge)
- Secondary Procedures(30 Days, 6 Month and Years 1 to 5)
- Conversion to Open Repair(Procedurally and to 5 Years)
- Procedural/In-hospital Evaluations(Procedurally and to hospital discharge)
Investigators
Study Sites (8)
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