Who is sponsoring NCT02949297?

NCT02949297 is sponsored by Endologix.

What drugs are being tested in NCT02949297?

Interventions in NCT02949297: Ovation Alto Abdominal Stent Graft System.

What condition does NCT02949297 study?

NCT02949297 studies Aortic Aneurysm, Abdominal.

Is NCT02949297 still recruiting?

NCT02949297 is currently completed. Last updated 22 December 2021.

Are results published for NCT02949297?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-22 · How we verify

NCT02949297: ELEVATE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 22 December 2021

What this trial tests

NA trial testing Ovation Alto Abdominal Stent Graft System in Aortic Aneurysm, Abdominal in 75 participants. Completed in 6 March 2019.

Timeline

30 March 2017

Primary endpoint
6 March 2019

6 March 2019

Quick facts

Lead sponsor	Endologix
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	30 March 2017
Primary completion	6 March 2019
Estimated completion	6 March 2019
Sites	13 locations across United States

Drugs / interventions tested

Ovation Alto Abdominal Stent Graft System

Conditions studied

Aortic Aneurysm, Abdominal — all drugs for Aortic Aneurysm, Abdominal →

Sponsor

Endologix

Who can join

18 and older, any sex, with Aortic Aneurysm, Abdominal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Treatment Success Primary · 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 int

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	58

Event Rates for Endoleaks Secondary · 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 II

1 month : Type I

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

1 month : Type Ia

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	1

1 month : Type Ib

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

1 month : Type II

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	34

1 month : Type III

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

1 month : Type IIIA

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

1 month : Type IIIB

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

1 month : Type IV

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Number of Participants With Stent Graft Migration > 10mm Secondary · 6 months, 12 months

any change of stent graft migration (movement) greater than 10mm

6 Months

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

1 Year

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Number of Participants With AAA Enlargement > 5mm Secondary · 6 months, 12 months

Change in aneurysm diameter greater than 5mm

6 months

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

12 months

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	1

Number of Participants With AAA Rupture Secondary · 30 day, Day 31-365

A tear in the abdominal aorta that can result in serious internal bleeding.

1 month

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Day 31-365

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Number of Participants With Conversion to Open Repair Secondary · 30 day, Day 31-365

conversion to open abdominal surgery to repair AAA

30 day

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Day 31 to 365

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	1

Number of Secondary Interventions Secondary · 30 days, Day 31-365

Intervention occurring after index procedure and having to do with device or AAA.

1 month

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Day 31 - 365

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	2

Number of Participants With AAA-related Mortality Secondary · 1 month, Day 31-365

death caused by or related to AAA

30 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Day 31 to 365

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Device-related Adverse Events (AEs) Secondary · 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

30 days : Infections and Infestations

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

30 days : Product Issues

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	1

Day 31-365 : Infections and Infestations

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	1

Day 31-365 : Product Issues

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Major Adverse Events Secondary · 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)

Deaths : 30 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Deaths : 31-365 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	3

Bowel Ischemia : 30 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	3

Bowel Ischemia : 31-365 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Myocardial Infarction : 30 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Myocardial Infarction : 31-365 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	1

Paralysis : 30 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Paralysis : 31-365 days

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression) Secondary · 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.

1 Month

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

6 Months

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

1 Year

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Number of Participants With Stent Fracture Secondary · 1 month, 6 months, 12 months

1 month

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

6 months

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

12 months

Group	Value	95% CI
Ovation Alto Abdominal Stent Graft System	0

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected over 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ovation Alto Abdominal Stent Graft System

Serious: 11/75 (15%)

Deaths: 3/75

Serious adverse events (9 terms)

Reaction	System	Ovation Alto Abdominal Ste…
Bowel Ischemia	Gastrointestinal disorders	—
Endoleak Ia	Product Issues	—
Aneurysm Expansion	Vascular disorders	—
Procedural Blood Loss	Injury, poisoning and procedural complications	—
Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Device Infection	Infections and infestations	—
Other	Nervous system disorders	—
Myocardial Infarction	Cardiac disorders	—
Unknown Cause of Death	Cardiac disorders	—

Other adverse events (86 terms — click to expand)

Reaction	System	Ovation Alto Abdominal Ste…
Endoleak II	General disorders	—
Arrhythmia	Cardiac disorders	—
Congestive Heart Failure	Cardiac disorders	—
UTI	Infections and infestations	—
anemia	Blood and lymphatic system disorders	—
Acute Renal Failure	Renal and urinary disorders	—
Claudication	Vascular disorders	—
diarrhea	Gastrointestinal disorders	—
Adynamic Ileus	Gastrointestinal disorders	—
Angina	Cardiac disorders	—
Anticoagulant Related Bleeding	General disorders	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—
Bone Fracture	Musculoskeletal and connective tissue disorders	—
COPD	Infections and infestations	—
Deep Vein Thrombosis	Vascular disorders	—
Edema	Cardiac disorders	—
Embolism	Vascular disorders	—
Endoleak IA	General disorders	—
Hypertension	Vascular disorders	—
Hypotension	Vascular disorders	—
Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Medication Reaction	Immune system disorders	—
Medication Reaction	General disorders	—
Numbness	General disorders	—
Routine CT scan done for follow up of AAA stent graft repair	Gastrointestinal disorders	—
plaque obstructing true lumen (iliofemoral endarterectomy)	Vascular disorders	—
Hematuria	Injury, poisoning and procedural complications	—
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	—
Blood in urine	Renal and urinary disorders	—
hypoxemia	Respiratory, thoracic and mediastinal disorders	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—
Pneumonia	Infections and infestations	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—
Sub-Dermal Hematoma	Injury, poisoning and procedural complications	—
Syncope (Cardiac)	Cardiac disorders	—
Syncope (cardiac)	Nervous system disorders	—
TIA	Nervous system disorders	—
Urinary Retention	Renal and urinary disorders	—
Valve Disorder	Cardiac disorders	—
Restrictive lung disease	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Bowel Ischemia, Endoleak Ia, Aneurysm Expansion, Procedural Blood Loss, Lung Cancer, Device Infection, Other, Myocardial Infarction.

Data from ClinicalTrials.gov NCT02949297 adverse events section.

Sponsor's own 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Aortic Aneurysm, Abdominal

Currently open trials in the same condition.

NCT06488898 — Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts · Phase 2 · recruiting
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NCT04503395 — ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES · NA · recruiting
NCT05360108 — Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm · active not recruiting
NCT02489539 — Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms · NA · active not recruiting

Other Endologix trials

Trials by the same sponsor.

NCT06315023 — The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) · recruiting
NCT04625660 — Detour2 Continued Access Study · NA · completed
NCT04130737 — TORUS 2 IDE Clinical Study · NA · active not recruiting
NCT03119233 — The DETOUR 2 Clinical Trial · NA · completed
NCT03298477 — EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02949297 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endologix
Last refreshed: 22 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02949297.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02949297: ELEVATE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (9 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Aortic Aneurysm, Abdominal

Other Endologix trials

Verify against primary sources