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

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ClinicalTrials.gov Identifier: NCT02949297
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Device: Ovation Alto Abdominal Stent Graft System

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 15 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  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft IDE Study
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Ovation Alto Abdominal Stent Graft System
Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.
Device: Ovation Alto Abdominal Stent Graft System
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System



Primary Outcome Measures :
  1. Number of Subjects with treatment success [ Time Frame: 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 :
  1. Number and Classification of Endoleaks [ Time Frame: 1, 6, and 12 months ]
  2. Stent Graft Migration > 10mm [ Time Frame: 1, 6, and 12 months ]
  3. AAA enlargement > 5mm [ Time Frame: 1, 6, and 12 months ]
  4. AAA rupture [ Time Frame: 1, 6, and 12 months ]
  5. Conversion to open repair [ Time Frame: 1, 6, and 12 months ]
  6. Number of Secondary Interventions [ Time Frame: 1, 6, and 12 months ]
  7. AAA-related mortality [ Time Frame: 1, 6, and 12 months ]
  8. Device-related Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 1, 6, and 12 months ]
  9. Major Adverse Events [ Time Frame: 1, 6, and 12 months ]
  10. Loss of patency [ Time Frame: 1, 6, and 12 months ]
  11. Stent fracture [ Time Frame: 1, 6, and 12 months ]
  12. Thromboembolic event [ Time Frame: 1, 6, and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949297


Contacts
Contact: Noel L Smith, BS 707-543-8696 nsmith@endologix.com
Contact: Aabha Bamba abamba@endologix.com

Locations
United States, Arizona
Abrazo Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85016
Principal Investigator: Venkatesh Ramaiah, MD         
United States, California
VA San Diego Recruiting
San Diego, California, United States, 92161
Principal Investigator: Andrew Barleben, MD, MPH         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Heron Rodriguez, MD         
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Principal Investigator: Syed Hussain, MD         
United States, Kentucky
University of Kentucky Not yet recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: David J. Minion, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Christopher Kwolek, MD         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Principal Investigator: Steve Henao, MD         
United States, New York
University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Principal Investigator: Sonya Noor, MD         
United States, North Carolina
Mission Hospital Recruiting
Asheville, North Carolina, United States, 28801
Principal Investigator: John Henretta, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Sean Lyden, MD         
United States, South Dakota
North Central Heart Recruiting
Sioux Falls, South Dakota, United States, 57108
Principal Investigator: J. Michael Bacharach, MD         
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Principal Investigator: Chris Metzger, MD         
United States, Texas
Baylor St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Zvonimir Krajcer, MD         
United States, Washington
EvergreenHealth Recruiting
Kirkland, Washington, United States, 98034
Principal Investigator: Mark Ombrellaro, MD         
Swedish Heart and Vascular Research Recruiting
Seattle, Washington, United States, 98122
Principal Investigator: Robert Bersin, MD         
Sponsors and Collaborators
Endologix
Investigators
Principal Investigator: Sean Lyden, MD The Cleveland Clinic

Additional Information:
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT02949297     History of Changes
Other Study ID Numbers: 771-0013
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Endologix:
abdominal
aortic
aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases