An interventional study of Pipeline™ Flex Embolization Device with Shield Technology™ in Intracranial Aneurysm and Ruptured Aneurysm, sponsored by Medtronic Neurovascular Clinical Affairs. Terminated at 7 sites in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Medtronic Neurovascular Clinical Affairs (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
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.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's enrollment of 25 is below the median of 100 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Medtronic Neurovascular Clinical Affairs is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Pipeline™ Flex Embolization Device with Shield Technology™
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.
Also known as: Pipeline™ Shield Device
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%.
Time frame: 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.
Time frame: at 365-day
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)
Scale for measuring general neurologic function: 0- No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
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
Plan to share: No — No individual participant data will be available.
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Oct 2025, 41 months.
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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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