Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

Not Applicable

Completed

Conditions: Aortic Aneurysm, Abdominal

Interventions: Device: Ovation Alto Abdominal Stent Graft System

Registration Number: NCT02949297

Lead Sponsor: Endologix

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovation Alto Abdominal Stent Graft System	Ovation Alto Abdominal Stent Graft System	Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment Success	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Device-related Adverse Events (AEs)	30 days, Day 31-365	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
Number of Participants With AAA Enlargement > 5mm	6 months, 12 months	Change in aneurysm diameter greater than 5mm
Number of Participants With Conversion to Open Repair	30 day, Day 31-365	conversion to open abdominal surgery to repair AAA
Number of Participants With AAA-related Mortality	1 month, Day 31-365	death caused by or related to AAA
Major Adverse Events	1 year	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)
Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)	1 month, 6 months, 12 months	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.
Number of Participants With Stent Fracture	1 month, 6 months, 12 months	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.
Adverse Events (Serious and Non-serious)	30 days, Day 31-365	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
Event Rates for Endoleaks	1 month, 6 months, 12 months	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.
Number of Participants With Stent Graft Migration > 10mm	6 months, 12 months	any change of stent graft migration (movement) greater than 10mm
Number of Participants With AAA Rupture	30 day, Day 31-365	A tear in the abdominal aorta that can result in serious internal bleeding.
Number of Secondary Interventions	30 days, Day 31-365	Intervention occurring after index procedure and having to do with device or AAA.
Procedure-related Adverse Event	30 days, Day 31-365	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
Serious Adverse Event	30 Days, Day31-365)	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

Trial Locations

Locations (13): North Central Heart
🇺🇸
Sioux Falls, South Dakota, United States
University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center
🇺🇸
Buffalo, New York, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Carle Foundation Hospital
🇺🇸
Urbana, Illinois, United States
Mission Hospital
🇺🇸
Asheville, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Wellmont CVA Heart Institute
🇺🇸
Kingsport, Tennessee, United States
Swedish Heart and Vascular Research
🇺🇸
Seattle, Washington, United States
Baylor St. Luke's Medical Center
🇺🇸
Houston, Texas, United States
New Mexico Heart Institute
🇺🇸
Albuquerque, New Mexico, United States
Abrazo Arizona Heart Hospital
🇺🇸
Phoenix, Arizona, United States
VA San Diego
🇺🇸
San Diego, California, United States