Aortic Aneurysm, AbdominalELEVATENCT02949297
Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
A study testing Ovation Alto Abdominal Stent Graft System in people with Aortic Aneurysm, Abdominal, run by Endologix at 13 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Ovation Alto Abdominal Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 13 sitesUnited States
- Study dates
- 30 Mar 2017to 6 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient has dissecting aneurysm.
- Patient has acutely ruptured aneurysm.
- Patient has need for emergent surgery.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Mission Hospital
Asheville, North Carolina, 28801
Massachusetts General Hospital
Boston, Massachusetts, 02114
University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center
Buffalo, New York, 14203
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
VA San Diego
San Diego, California, 92161
Swedish Heart and Vascular Research
Seattle, Washington, 98122
North Central Heart
Sioux Falls, South Dakota, 57108
Carle Foundation Hospital
Urbana, Illinois, 61801
About this study
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).
Read the 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.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Ovation Alto Abdominal Stent Graft System
- Keywords
- abdominal, aortic, aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovation Alto Abdominal Stent Graft SystemDevice
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Other | Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System. Receives: Device: Ovation Alto Abdominal Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (14)
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 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.
Measured: 1 month, 6 months, 12 months
Number of Participants With Stent Graft Migration > 10mm
any change of stent graft migration (movement) greater than 10mm
Measured: 6 months, 12 months
Number of Participants With AAA Enlargement > 5mm
Change in aneurysm diameter greater than 5mm
Measured: 6 months, 12 months
Number of Participants With AAA Rupture
A tear in the abdominal aorta that can result in serious internal bleeding.
Measured: 30 day, Day 31-365
Number of Participants With Conversion to Open Repair
conversion to open abdominal surgery to repair AAA
Measured: 30 day, Day 31-365
Number of Secondary Interventions
Intervention occurring after index procedure and having to do with device or AAA.
Measured: 30 days, Day 31-365
Number of Participants With AAA-related Mortality
death caused by or related to AAA
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 30 Days, Day31-365)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start30 Mar 2017
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Lyden, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949297
- Sponsor's protocol ID
- 771-0013
- Acronym
- ELEVATE
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2016
- Last updated
- 22 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36028158
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
- ClinicalTrials.gov ID
- NCT02949297
- Acronym / sponsor ID
- ELEVATE / 771-0013
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- abdominal, aortic, aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Posted 22 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovation Alto Abdominal Stent Graft System | Other | Device: Ovation Alto Abdominal Stent Graft SystemEndovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient has dissecting aneurysm.
- Patient has acutely ruptured aneurysm.
- Patient has need for emergent surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovation Alto Abdominal Stent Graft SystemRepair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System | Device | Ovation Alto Abdominal Stent Graft System |
Primary outcome
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.
14 secondary outcomes
Event Rates for Endoleaks
Time frame: 1 month, 6 months, 12 months
Number of Participants With Stent Graft Migration > 10mm
Time frame: 6 months, 12 months
Number of Participants With AAA Enlargement > 5mm
Time frame: 6 months, 12 months
Number of Participants With AAA Rupture
Time frame: 30 day, Day 31-365
Number of Participants With Conversion to Open Repair
Time frame: 30 day, Day 31-365
Number of Secondary Interventions
Time frame: 30 days, Day 31-365
Number of Participants With AAA-related Mortality
Time frame: 1 month, Day 31-365
Device-related Adverse Events (AEs)
Time frame: 30 days, Day 31-365
Major Adverse Events
Time frame: 1 year
Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)
Time frame: 1 month, 6 months, 12 months
Number of Participants With Stent Fracture
Time frame: 1 month, 6 months, 12 months
Adverse Events (Serious and Non-serious)
Time frame: 30 days, Day 31-365
Procedure-related Adverse Event
Time frame: 30 days, Day 31-365
Serious Adverse Event
Time frame: 30 Days, Day31-365)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36028158Lyden 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.
- Endologix WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Lyden, MD principal investigator
The Cleveland Clinic
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovation Alto Abdominal Stent Graft System in people with Aortic Aneurysm, Abdominal, run by Endologix at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Treatment Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.