Clinical trial NCT02949297: Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Official title: Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: abdominal
aortic
aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria include:

1. Patient has adequate iliac/femoral access compatible with the required delivery systems.
2. Patient has non-aneurysmal proximal aortic neck.
3. Patient has non-aneurysmal distal iliac landing zone.

Exclusion Criteria include:

1. Patient has dissecting aneurysm.
2. Patient has acutely ruptured aneurysm.
3. Patient has need for emergent surgery.

Primary outcomes:
measure: Number of Subjects With Treatment Success
timeFrame: 12 months
Secondary outcomes:
measure: Event Rates for Endoleaks
timeFrame: 1 month, 6 months, 12 months
measure: Number of Participants With Stent Graft Migration > 10mm
timeFrame: 6 months, 12 months
measure: Number of Participants With AAA Enlargement > 5mm
timeFrame: 6 months, 12 months
measure: Number of Participants With AAA Rupture
timeFrame: 30 day, Day 31-365
measure: Number of Participants With Conversion to Open Repair
timeFrame: 30 day, Day 31-365
measure: Number of Secondary Interventions
timeFrame: 30 days, Day 31-365
measure: Number of Participants With AAA-related Mortality
timeFrame: 1 month, Day 31-365
measure: Device-related Adverse Events (AEs)
timeFrame: 30 days, Day 31-365
measure: Major Adverse Events
timeFrame: 1 year
measure: Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)
timeFrame: 1 month, 6 months, 12 months
measure: Number of Participants With Stent Fracture
timeFrame: 1 month, 6 months, 12 months
measure: Adverse Events (Serious and Non-serious)
timeFrame: 30 days, Day 31-365
measure: Procedure-related Adverse Event
timeFrame: 30 days, Day 31-365
measure: Serious Adverse Event
timeFrame: 30 Days, Day31-365)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: San Diego
country: United States
facility: VA San Diego
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Buffalo
country: United States
facility: University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Heart and Vascular Research
state: Washington
Study officials:
affiliation: The Cleveland Clinic
name: Sean Lyden, MD
role: PRINCIPAL_INVESTIGATOR
References: