Study of anatomical fixation with a 34mm proximal extension
The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Endovascular abdominal aortic aneurysm repair
Mount Sinai Medical Center
Miami, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Baptist Hospital East
Louisville, Kentucky, United States
Number of Participants With Proximal Type I Endoleak at Each Timepoint
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
Time frame: Five years
Number of Participants With Successful Delivery and Deployment of the Device
Successful delivery and deployment of the device with no complication.
Time frame: 1 Month
Number of Participants With Type III Endoleaks at Each Timepoint
Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
Time frame: 5 Years
Number of Participants With Stent Fracture at Each Timepoint
Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.
Time frame: 5 Years
Number of Participants With Stent Graft Obstruction at Each Timepoint
Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.
Time frame: 5 Years
Number of Participants With Migration at Each Timepoint
Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.
Time frame: 5 Years
Number of Participants With Type II Endoleaks at Each Timepoint
Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
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St. Joseph Medical Center
Towson, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Sisters of Charity Hospital
Buffalo, New York, United States
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, United States
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Time frame: 5 Years
Number of Participants With Aneurysm Diameter Change at Each Timepoint
Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.
Time frame: 5 Years
Maximum Diameter Measurements
Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).
Time frame: 5 Years
Aneurysm Volume Measurements
Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.
Time frame: 5 Years