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.
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 pararenal aortic aneurysms. Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis. Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical repair; Type I endoleak after 30 days; Type III endoleak; clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
The Ventana Fenestrated Stent Graft System consists of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
University of Alabama at Birmingham
Birmingham, Alabama, United States
Safety- Number of Major Adverse Events at 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Time frame: 30 Days
Effectiveness
1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 4. Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Time frame: 1 Year
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Time frame: >30 Days to 5 Years
Renal Dysfunction
Renal Dysfunction is calculated at greater than 30% reduction starting at baseline
Time frame: Discharge to 5 Years
Endoleaks
Endoleaks- Type IA, Type IB, Type II, Type IIIA, Type IIIB, Type IV, and Unknown Type Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
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Arizona Heart Institute
Phoenix, Arizona, United States
John Muir Medical Center Concord, CA
Concord, California, United States
UCLA Medical Center
Los Angeles, California, United States
VA Gainesville
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Baptist East Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
...and 12 more locations
Time frame: 30 Days to 5 Years
Clinical Utility Outcomes
Clinical Utility Outcomes consist of: fluoroscopy time, Bifurcated device placement time, Renal Artery Cannulation time, F-EVAR time and total procedure time.
Time frame: At the time of the procedure
Time in ICU
Number of days spent in the intensive care unit (ICU)
Time frame: In-Hospital
Time to Hospital Discharge
Number of days from the index procedure to discharge from the hospital.
Time frame: Hospital Discharge (Post-Procedure)
Device Patency
Device patency- Ventana \& Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion
Time frame: 30 Days to 5 Years
Device Integrity
Device Integrity- Device Migration, Ventana Stent Fracture, Left Renal Stent Fracture, Right Renal Stent Fracture, and Stent Kinking/ Compression
Time frame: 30 Days to 5 Years
Aneurysm Sac Morphology
Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement
Time frame: 30 Days to 5 Years
Aneurysm Sac Diameter
Aneurysm Sac diameter changes
Time frame: 30 Days to 5 Years
Clinical Utility Outcomes
Clinical Utility Outcomes consists of: contrast volume and estimated blood loss.
Time frame: At the time of the procedure