Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
NCT ID: NCT02949297
Last Updated: 2021-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2017-03-30
2019-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ovation Alto Abdominal Stent Graft System
Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.
Ovation Alto Abdominal Stent Graft System
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
Interventions
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Ovation Alto Abdominal Stent Graft System
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
Eligibility Criteria
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Inclusion Criteria
2. Patient has non-aneurysmal proximal aortic neck.
3. Patient has non-aneurysmal distal iliac landing zone.
Exclusion Criteria
2. Patient has acutely ruptured aneurysm.
3. Patient has need for emergent surgery.
18 Years
ALL
No
Sponsors
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Endologix
INDUSTRY
Responsible Party
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Principal Investigators
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Sean Lyden, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
VA San Diego
San Diego, California, United States
Northwestern University
Chicago, Illinois, United States
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
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Swedish Heart and Vascular Research
Seattle, Washington, United States
Countries
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References
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Lyden SP, Metzger DC, Henao S, Noor S, Barleben A, Henretta JP, Kirksey L. One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial. J Vasc Surg. 2023 Feb;77(2):446-453.e3. doi: 10.1016/j.jvs.2022.08.016. Epub 2022 Aug 24.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Endologix Website
Other Identifiers
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771-0013
Identifier Type: -
Identifier Source: org_study_id
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