Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02949297
Recruitment Status : Completed
First Posted : October 31, 2016
Results First Posted : December 22, 2021
Last Update Posted : December 22, 2021
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 Phase
Aortic Aneurysm, Abdominal Device: Ovation Alto Abdominal Stent Graft System Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : March 6, 2019
Actual Study Completion Date : March 6, 2019

Resource links provided by the National Library of Medicine


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. Event Rates for Endoleaks [ Time Frame: 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.

  2. Number of Participants With Stent Graft Migration > 10mm [ Time Frame: 6 months, 12 months ]
    any change of stent graft migration (movement) greater than 10mm

  3. Number of Participants With AAA Enlargement > 5mm [ Time Frame: 6 months, 12 months ]
    Change in aneurysm diameter greater than 5mm

  4. Number of Participants With AAA Rupture [ Time Frame: 30 day, Day 31-365 ]
    A tear in the abdominal aorta that can result in serious internal bleeding.

  5. Number of Participants With Conversion to Open Repair [ Time Frame: 30 day, Day 31-365 ]
    conversion to open abdominal surgery to repair AAA

  6. Number of Secondary Interventions [ Time Frame: 30 days, Day 31-365 ]
    Intervention occurring after index procedure and having to do with device or AAA.

  7. Number of Participants With AAA-related Mortality [ Time Frame: 1 month, Day 31-365 ]
    death caused by or related to AAA

  8. Device-related Adverse Events (AEs) [ Time Frame: 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

  9. Major Adverse Events [ Time Frame: 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)

  10. Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) [ Time Frame: 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.

  11. Number of Participants With Stent Fracture [ Time Frame: 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.

  12. Adverse Events (Serious and Non-serious) [ Time Frame: 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

  13. Procedure-related Adverse Event [ Time Frame: 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

  14. Serious Adverse Event [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Locations
Layout table for location information
United States, Arizona
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States, 85016
United States, California
VA San Diego
San Diego, California, United States, 92161
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
United States, New York
University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center
Buffalo, New York, United States, 14203
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, South Dakota
North Central Heart
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
United States, Texas
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Heart and Vascular Research
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Endologix
Investigators
Layout table for investigator information
Principal Investigator: Sean Lyden, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Endologix:
Additional Information:
Layout table for additonal information
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT02949297    
Other Study ID Numbers: 771-0013
First Posted: October 31, 2016    Key Record Dates
Results First Posted: December 22, 2021
Last Update Posted: December 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Endologix:
abdominal
aortic
aneurysm
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases