Endologix Infrarenal Bifurcated Stent Graft Study
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Endovascular abdominal aortic aneurysm repair
Open surgical abdominal aortic aneurysm repair
Arizona Heart Institute
Phoenix, Arizona, United States
Harbor-UCLA Medical Center
Torrance, California, United States
University of Illinois School of Medicine
Peoria, Illinois, United States
No of Subjects with Major adverse events
Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke
Time frame: At 1 Year
All Cause Mortality
No of deaths reported through 1 year
Time frame: At 1 Year
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time frame: 30 Days
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time frame: 6 Months
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time frame: Year 1
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time frame: Year 2
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time frame: Year 3
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
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SIU School of Medicine
Springfield, Illinois, United States
Mercy Hospital
Des Moines, Iowa, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Advanced Vascular Associates
Morristown, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
...and 4 more locations
Time frame: Year 4
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Time frame: Year 5
Clinical Utility Outcomes
Estimated anesthesia time, fluoroscopy time, procedure time
Time frame: During the Procedure
Clinical Utility Outcomes
Estimated blood loss (ml) and contrast volume (ml). Estimated blood loss records the approximate amount of blood that the patient lost during the surgery (ml) and contract volume is the volume of the contrast (ml) calculated during the procedure.
Time frame: During the Procedure
Clinical Utility Outcomes
Estimated ICU time
Time frame: up to 1 week
Clinical Utility Outcomes
Estimated Hospitalization Time
Time frame: up to 1 week
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months
Time frame: 6 Months
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1
Time frame: Year 1
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2
Time frame: Year 2
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3
Time frame: Year 3
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4
Time frame: Year 4
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5
Time frame: Year 5