Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
ELEVATE
1 other identifier
interventional
75
1 country
13
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2019
CompletedResults Posted
Study results publicly available
December 22, 2021
CompletedDecember 22, 2021
November 1, 2021
1.9 years
October 21, 2016
September 30, 2021
November 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (14)
Event Rates for Endoleaks
1 month, 6 months, 12 months
Number of Participants With Stent Graft Migration > 10mm
6 months, 12 months
Number of Participants With AAA Enlargement > 5mm
6 months, 12 months
Number of Participants With AAA Rupture
30 day, Day 31-365
Number of Participants With Conversion to Open Repair
30 day, Day 31-365
- +9 more secondary outcomes
Study Arms (1)
Ovation Alto Abdominal Stent Graft System
OTHEREndovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.
Interventions
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
Eligibility Criteria
You may qualify if:
- Patient has adequate iliac/femoral access compatible with the required delivery systems.
- Patient has non-aneurysmal proximal aortic neck.
- Patient has non-aneurysmal distal iliac landing zone.
You may not qualify if:
- Patient has dissecting aneurysm.
- Patient has acutely ruptured aneurysm.
- Patient has need for emergent surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endologixlead
Study Sites (13)
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016, United States
VA San Diego
San Diego, California, 92161, United States
Northwestern University
Chicago, Illinois, 60611, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center
Buffalo, New York, 14203, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
North Central Heart
Sioux Falls, South Dakota, 57108, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
Swedish Heart and Vascular Research
Seattle, Washington, 98122, United States
Related Publications (1)
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.
PMID: 36028158DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Clinical Affairs
- Organization
- Endologix, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Lyden, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 31, 2016
Study Start
March 30, 2017
Primary Completion
March 6, 2019
Study Completion
March 6, 2019
Last Updated
December 22, 2021
Results First Posted
December 22, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share