The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Kaiser Permanente Zion Medical Center
San Diego, California, United States
Stanford Hospital & Clinics
Stanford, California, United States
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
Time frame: 30-days
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco
Time frame: 12-months
All-cause Mortality
All-cause mortality (ACM) within 30, 183, 365 days
Time frame: within 30, 183, and 365 days
Aneurysm-related Mortality (ARM)
Aneurysm-related mortality (ARM) within 30, 183, and 365 days
Time frame: within 30, 183, and 365 days
Secondary Procedures to Correct Type I and III Endoleaks
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Medstar Heart & Vascular Institute
Washington D.C., District of Columbia, United States
Maine Medical Center
Portland, Maine, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health Sysem
Ann Arbor, Michigan, United States
Long Island Jewish Northshore University Hospital
New Hyde Park, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
...and 4 more locations
Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days. Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak.
Time frame: within 183, and 365 days
Secondary Procedures
Secondary procedures within 183 and 365 days
Time frame: within 183, and 365 days
Serious Adverse Events
Serious adverse events within 30, 183 and 365 days.
Time frame: within 30, 183, and 365 days
Conversion to Open Surgery
Conversion to open surgery within 183, and 365 days
Time frame: within 183, and 365 days
Aneurysm Rupture
Aneurysm rupture within 183 and 365 days
Time frame: within 183 and 365 days
Major Adverse Events
Major adverse events within 183 and 365 days
Time frame: within 183 and 365 days
Stent Graft Migration
Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging). Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature. Migration is observed when the stent graft completely covers a renal artery or movement is \> 10 mm either distally or proximally. Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is \> 10 mm or coverage of the internal iliac artery.
Time frame: At 6- and 12-month follow-up visits (as compared to 1-month imaging)
Aneurysm Expansion >5 mm
Aneurysm expansion \>5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging)
Time frame: at 6- and 12-month follow-up visits (as compared to 1-month imaging)
All Endoleaks Based on Imaging Findings
All endoleaks based on imaging findings at 1-month, 6-month and 12-month. An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality.
Time frame: at 1-, 6-, and 12-month follow-up visits
Stent Graft Occlusions Based on Imaging Findings
Stent graft occlusions based on imaging findings through 1-, 6- and 12 months. Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis.
Time frame: Through 1-, 6- and 12 months
Device Deficiencies Based on Imaging Findings
Device deficiencies based on imaging findings through 6- and 12 months. A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref. ISO 14155:2011 3.15).
Time frame: Through 6- and 12 months