A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).
A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
VA San Diego
San Diego, California, United States
Northwestern University
Chicago, Illinois, United States
Number of Subjects With Treatment Success
Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration \> 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement \>5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.
Time frame: 12 months
Event Rates for Endoleaks
Endoleak is defined by the persistence of blood flow outside the lumen of the endovascular graft but within the aneurysm sac and can be classified as: * Type I - Ineffective seal at either the proximal or distal sealing zones * Type IA - Ineffective seal at the proximal sealing zone * Type IB - Ineffective seal at the distal sealing zone * Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac * Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration * Type IIIA - Junctional leak or component disconnection * Type IIIB - Midgraft hole * Type IV - Blood flow through an intact fabric. * Unknown endoleak - Endoleak present but unable to assess type Endoleak will only be evaluated as an adverse event or serious adverse event if it is present at the 30-day follow-up visit or if a post-index procedure re-intervention occurs.
Time frame: 1 month, 6 months, 12 months
Number of Participants With Stent Graft Migration > 10mm
any change of stent graft migration (movement) greater than 10mm
Time frame: 6 months, 12 months
Number of Participants With AAA Enlargement > 5mm
Change in aneurysm diameter greater than 5mm
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Carle Foundation Hospital
Urbana, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center
Buffalo, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
North Central Heart
Sioux Falls, South Dakota, United States
...and 3 more locations
Time frame: 6 months, 12 months
Number of Participants With AAA Rupture
A tear in the abdominal aorta that can result in serious internal bleeding.
Time frame: 30 day, Day 31-365
Number of Participants With Conversion to Open Repair
conversion to open abdominal surgery to repair AAA
Time frame: 30 day, Day 31-365
Number of Secondary Interventions
Intervention occurring after index procedure and having to do with device or AAA.
Time frame: 30 days, Day 31-365
Number of Participants With AAA-related Mortality
death caused by or related to AAA
Time frame: 1 month, Day 31-365
Device-related Adverse Events (AEs)
Device-Related: Event is caused or contributed by any component of the device during delivery, deployment or while the device is in situ post-operatively
Time frame: 30 days, Day 31-365
Major Adverse Events
Major adverse events (MAE) are defined as any one of the following events: * Death * Myocardial Infarction * Stroke (excludes TIA) * Renal Failure (excludes renal insufficiency) * Respiratory Failure (excludes chronic obstructive pulmonary disease (COPD) or pulmonary complications) * Paralysis (excludes paraparesis) * Bowel Ischemia * Procedural Blood Loss (≥1,000 cc)
Time frame: 1 year
Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)
The integrity of the stent graft is evaluated by the Independent Core Lab via abdominal X-rays at regularly scheduled follow-up visits. Any fractured stents, and any other issues compromising the integrity of the stent graft will be reported.
Time frame: 1 month, 6 months, 12 months
Number of Participants With Stent Fracture
The integrity of the stent graft is evaluated by the Independent Core Lab via abdominal X-rays at regularly scheduled follow-up visits. Any fractured stents, and any other issues compromising the integrity of the stent graft will be reported.
Time frame: 1 month, 6 months, 12 months
Adverse Events (Serious and Non-serious)
An adverse event is any new, undesirable medical occurrence or change (worsening) of a pre-existing condition that occurs in a subject, whether or not considered to be associated with the product
Time frame: 30 days, Day 31-365
Procedure-related Adverse Event
Procedure-Related event is caused or contributed by the initial study device implantation (index) procedure, up to 30 days, unless a different etiology can be identified
Time frame: 30 days, Day 31-365
Serious Adverse Event
A serious adverse event (SAE) defined as one that suggests a significant hazard or side effect, regardless of the investigator or Sponsor's opinion on the relationship to the investigational product. This includes, but may not be limited to, any event that: * Is fatal * Is life-threatening * Requires or prolongs (\>48 hours) inpatient hospitalization * Is a persistent or significant disability or incapacity * Is considered an important medical event
Time frame: 30 Days, Day31-365)