The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.
This is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm clinical trial. The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis in standard EVAR subjects. Subjects are randomized on a 1:1 basis to receive EVAR with either a Medtronic Endurant II/IIs Stent Graft Systems or Gore Excluder / Excluder Conformable AAA Endoprosthesis. Data is collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Approximately 600 subjects are planned to be enrolled at up to 100 sites globally. Product Names: * Medtronic Endurant II/IIs Stent Graft System * Gore Excluder and/or Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
EVAR treatment with Excluder / Excluder Conformable Stent Graft System
Loma Linda University Medical Center
Loma Linda, California, United States
RECRUITINGHoag Hospital
Newport Beach, California, United States
RECRUITINGUniversity of California Irvine Medical Center
Orange, California, United States
RECRUITINGUniversity of California Davis Medical Center
Sacramento, California, United States
Sac Regression
Proportion of patients with sac regression at 1 year, defined in accordance with SVS guidelines as the reduction in maximum diameter by \>= 5 mm when compared to the first CT imaging study obtained within 90 days after index procedure.
Time frame: 12 months
Aneurysm sac change by diameter as a continuous variable
Time frame: 12 months and annually to 5 years
Aneurysm sac change by volume incidence rate
Time frame: 12 months and annually to 5 years
Type II endoleak incidence rate
Time frame: 30 days, 12 months and annually to 5 years
Type I endoleak incidence rate
Time frame: 30 days,12 months and annually to 5 years
Secondary intervention incidence rate
Time frame: 30 days, 12 months and annually to 5 years
All cause mortality incidence rate
Time frame: 30 days, 12 months and annually to 5 years
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University of California San Francisco UCSF Medical Center
San Francisco, California, United States
RECRUITINGDenver Health Medical Center
Denver, Colorado, United States
RECRUITINGYale Center for Clinical Investigation
New Haven, Connecticut, United States
RECRUITINGMedstar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGSarasota Memorial Hospital
Sarasota, Florida, United States
RECRUITING...and 58 more locations