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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Endovascular repair of juxtarenal or pararenal aortic aneurysm
Pontificia Universidad Católica de Chile
Santiago, Chile
Auckland City Hospital
Auckland, New Zealand
Safety - Number of Major Adverse Events (MAEs)
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Time frame: 30 Days
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration
Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
Time frame: 30 Days
Safety - Number of Major Adverse Events (MAEs)
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
Adverse Events
All adverse events, whether serious or non-serious
Time frame: Procedurally to 5 Years
Distal Blood Flow
Ankle-brachial index measurements
Time frame: Discharge to 5 Years
Renal Dysfunction
eGFR reduction \>30% from baseline
Time frame: Discharge to 5 Years
Device Performance
Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
Time frame: 30 Days to 5 Years
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