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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: 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 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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Abrazo Arizona Heart Hospital
  • California
    • San Diego, California, United States, 92161
      • VA San Diego
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor St. Luke's Medical Center
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Heart and Vascular Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Rates for Endoleaks	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 zonesType IA - Ineffective seal at the proximal sealing zoneType 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.	1 month, 6 months, 12 months
Number of Participants With Stent Graft Migration > 10mm	any change of stent graft migration (movement) greater than 10mm	6 months, 12 months
Number of Participants With AAA Enlargement > 5mm	Change in aneurysm diameter greater than 5mm	6 months, 12 months
Number of Participants With AAA Rupture	A tear in the abdominal aorta that can result in serious internal bleeding.	30 day, Day 31-365
Number of Participants With Conversion to Open Repair	conversion to open abdominal surgery to repair AAA	30 day, Day 31-365
Number of Secondary Interventions	Intervention occurring after index procedure and having to do with device or AAA.	30 days, Day 31-365
Number of Participants With AAA-related Mortality	death caused by or related to AAA	1 month, Day 31-365
Device-related Adverse Events (AEs)	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	30 days, Day 31-365
Major Adverse Events	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)	1 year
Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)	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.	1 month, 6 months, 12 months
Number of Participants With Stent Fracture	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.	1 month, 6 months, 12 months
Adverse Events (Serious and Non-serious)	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	30 days, Day 31-365
Procedure-related Adverse Event	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	30 days, Day 31-365
Serious Adverse Event	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	30 Days, Day31-365)

Collaborators and Investigators

• Sponsor: Endologix

Publications and helpful links

Helpful Links

• Endologix Website

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): March 6, 2019

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: aneurysm; aortic; abdominal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 771-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes