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

• 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: Endologix
• Information provided by (Responsible Party): Endologix

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Sean Lyden, MD; The Cleveland Clinic

  Study Documents (Full-Text)

Documents provided by Endologix:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] August 23, 2017

More Information

Additional Information:

Endologix Website 

• Responsible Party: Endologix
• ClinicalTrials.gov Identifier: NCT02949297
• Other Study ID Numbers: 771-0013
• First Posted: October 31, 2016
• 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

• 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:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases