Intracranial AneurysmELEVATENCT04391803
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
A study testing Pipeline™ Flex Embolization Device with Shield Technology™ in people with Intracranial Aneurysm and Ruptured Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 7 sites in United States.
Trial summary
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Intracranial Aneurysm, Ruptured Aneurysm
- What is being tested?
- Pipeline™ Flex Embolization Device with Shield Technology™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 May 2022to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a previously untreated, wide neck, side-wall, intradural aneurysm that is deemed unfavorable for both surgical clipping and endovascular coiling, as confirmed on DSA.
- Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device.
- Subject is ≥ 22 and ≤ 80 years of age.
- Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3.
- Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.
Who cannot join
- Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device.
- Subject has aneurysm vessel characteristics that would preclude the device from fully conforming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement.
- Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device.
- Subject with intraparenchymal hemorrhage.
- Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement.
- Subject has a pre-morbid mRS >2.
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- Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm.
- Subject has a target ruptured aneurysm that is thought to be mycotic, including those caused by left atrial myxoma, or subject has an active systemic bacterial infection.
- Subject with a requirement for continuous anti-coagulation.
- Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenous malformation).
- Subject's target ruptured aneurysm has not been determined by the treating physician to be the source of SAH.
- Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum).
- Subject has a known hypersensitivity to ticagrelor or aspirin.
- Subject is unable to undergo DSA or DSA is determined unsuitable by the treating physician.
- Subject has a serious or life-threatening comorbidity that could confound study results.
- Subject is at high risk of noncompliance per treating physician due to reasons including but not limited to a history of substance abuse.
- Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 24 months.
- Subject is pregnant, or breastfeeding at the time of admission or plans to become pregnant during their participation in the study.
- Subject is participating in another clinical study at the time of enrollment.
- Presumed septic embolus, or suspicion of microbial superinfection.
- Subject with a known COVID-19 viral infection, confirmed by testing.
- Subject in whom a pre-existing stent is in place in the parent artery at target aneurysm location.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rush University Medical Center
Chicago, Illinois, 60612
Geisinger Medical Center
Danville, Pennsylvania, 17822
University of Kentucky Albert B Chandler Hospital
Lexington, Kentucky, 40506
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
Semmes Murphey Clinic
Memphis, Tennessee, 38120
Yale New Haven Hospital
New Haven, Connecticut, 06510
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
Read the detailed description
The ELEVATE study is a prospective, multi-center, single-arm trial of the Pipeline™ Shield Device for the treatment of adults with acutely ruptured intracranial aneurysms. The primary objective of the ELEVATE study is to assess the safety and effectiveness of treatment with the Pipeline™ Shield Device of acutely ruptured intracranial aneurysms that are not amenable for clipping and coiling.
- Conditions
- Intracranial Aneurysm, Ruptured Aneurysm
- Being tested
- Pipeline™ Flex Embolization Device with Shield Technology™
- Keywords
- wide neck, intradural aneurysm
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipeline™ Flex Embolization Device with Shield Technology™Device
Also called Pipeline™ Shield Device
The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular treatment of adults with intracranial acutely ruptured aneurysms not amenable to clipping and coiling.
| Study group | Role | What they receive |
|---|---|---|
| Pipeline™ Flex Embolization Device with Shield Technology™ | Experimental | This is a prospective, single-arm study in which subjects have consented and deployment of the Pipeline™ Flex Embolization Device with Shield Technology™ is attempted. Receives: Device: Pipeline™ Flex Embolization Device with Shield Technology™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm
Occlusion is measured by the Raymond Roy Scale. Significant stenosis is classified as ≤ 50%.
Measured: at 365-day
Incidence of neurological death or disabling stroke post-procedure.
Disabling stroke is defined as any post-procedural ischemic or hemorrhagic event that results in poor functional outcome (i.e. mRS ≥ 3 points) assessed at 90 days post stroke event.
Measured: at 365-day
Secondary outcomes (12)
Pipeline™ Flex Device Deployment Success Rate
Measured: Day 0 During Procedure
Incidence of rebleed of target aneurysm
Measured: through 180-day and 365-day post procedure
Incidence of neurological hemorrhagic serious adverse events
Measured: through 180-day and 365-day post procedure
Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days
Measured: through 180-day and 365-day post procedure
Incidence of any ipsilateral stroke post-procedure after 30 days
Measured: through 180-day and 365-day post procedure
Good clinical outcome (modified Rankin Scale (mRS) 0-2)
Scale for measuring general neurologic function:
0- No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: at 30-day, 180-day and 365-day post procedure
Incidence of parent artery thrombosis
Measured: through 365-day post procedure
Incidence of in-construct stenosis > 50%
Measured: through 365-day post procedure
Incidence of retreatment
Measured: through 180-day and 365-day post procedure
Incidence of peri-/post-procedural serious adverse events related to the device, procedure or antiplatelet therapy
Measured: through 180-day and 365-day post procedure
Incidence of neurological death or disabling stroke
Measured: through 365-day post procedure
Incidence of complete angiographic occlusion without significant stenosis (≤ 50%), and no rebleeding or retreatment of the target aneurysm
Measured: through 365-day post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start6 May 2022
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Why it stopped: Sponsor-initiated suspension to halt enrollment. Subjects that were enrolled were followed to completion. Last Subject Last Visit occurred on 20-Oct-2025.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fiorella, MD, Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391803
- Sponsor's protocol ID
- MDT19025TRACER
- Acronym
- ELEVATE
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2020
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
- ClinicalTrials.gov ID
- NCT04391803
- Acronym / sponsor ID
- ELEVATE / MDT19025TRACER
- Conditions
- Intracranial Aneurysm, Ruptured Aneurysm
- Keywords
- wide neck, intradural aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor-initiated suspension to halt enrollment. Subjects that were enrolled were followed to completion. Last Subject Last Visit occurred on 20-Oct-2025.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
Detailed description
The ELEVATE study is a prospective, multi-center, single-arm trial of the Pipeline™ Shield Device for the treatment of adults with acutely ruptured intracranial aneurysms. The primary objective of the ELEVATE study is to assess the safety and effectiveness of treatment with the Pipeline™ Shield Device of acutely ruptured intracranial aneurysms that are not amenable for clipping and coiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pipeline™ Flex Embolization Device with Shield Technology™ | Experimental | Device: Pipeline™ Flex Embolization Device with Shield Technology™This is a prospective, single-arm study in which subjects have consented and deployment of the Pipeline™ Flex Embolization Device with Shield Technology™ is attempted. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has a previously untreated, wide neck, side-wall, intradural aneurysm that is deemed unfavorable for both surgical clipping and endovascular coiling, as confirmed on DSA.
- Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device.
- Subject is ≥ 22 and ≤ 80 years of age.
- Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3.
- Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.
Key exclusion criteria (22 listed)
- Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device.
- Subject has aneurysm vessel characteristics that would preclude the device from fully conforming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement.
- Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device.
- Subject with intraparenchymal hemorrhage.
- Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement.
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 |
|---|---|---|
| Pipeline™ Flex Embolization Device with Shield Technology™Also: Pipeline™ Shield DeviceThe Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular treatment of adults with intracranial acutely ruptured aneurysms not amenable to clipping and coiling. | Device | Pipeline™ Flex Embolization Device with Shield Technology™ |
Primary outcome
Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm
Time frame: at 365-day
Occlusion is measured by the Raymond Roy Scale. Significant stenosis is classified as ≤ 50%.
Incidence of neurological death or disabling stroke post-procedure.
Time frame: at 365-day
Disabling stroke is defined as any post-procedural ischemic or hemorrhagic event that results in poor functional outcome (i.e. mRS ≥ 3 points) assessed at 90 days post stroke event.
12 secondary outcomes
Pipeline™ Flex Device Deployment Success Rate
Time frame: Day 0 During Procedure
Incidence of rebleed of target aneurysm
Time frame: through 180-day and 365-day post procedure
Incidence of neurological hemorrhagic serious adverse events
Time frame: through 180-day and 365-day post procedure
Incidence of ipsilateral major stroke or neurological death post-procedure after 30 days
Time frame: through 180-day and 365-day post procedure
Incidence of any ipsilateral stroke post-procedure after 30 days
Time frame: through 180-day and 365-day post procedure
Good clinical outcome (modified Rankin Scale (mRS) 0-2)
Time frame: at 30-day, 180-day and 365-day post procedure
Incidence of parent artery thrombosis
Time frame: through 365-day post procedure
Incidence of in-construct stenosis > 50%
Time frame: through 365-day post procedure
Incidence of retreatment
Time frame: through 180-day and 365-day post procedure
Incidence of peri-/post-procedural serious adverse events related to the device, procedure or antiplatelet therapy
Time frame: through 180-day and 365-day post procedure
Incidence of neurological death or disabling stroke
Time frame: through 365-day post procedure
Incidence of complete angiographic occlusion without significant stenosis (≤ 50%), and no rebleeding or retreatment of the target aneurysm
Time frame: through 365-day post procedure
Results and safety
The study was stopped early (reason given: Sponsor-initiated suspension to halt enrollment. Subjects that were enrolled were followed to completion. Last Subject Last Visit occurred on 20-Oct-2025.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. No individual participant data will be available.
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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.
David Fiorella, MD principal investigator
Stony Brook University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pipeline™ Flex Embolization Device with Shield Technology™ in people with Intracranial Aneurysm and Ruptured Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 7 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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: Sponsor-initiated suspension to halt enrollment. Subjects that were enrolled were followed to completion. Last Subject Last Visit occurred on 20-Oct-2025.). Results are not available in the source record.
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?
Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm (time frame: at 365-day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.