EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipelin… (NCT04391803) | Clinical Trial Compass
TerminatedNot Applicable
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
Stopped: Sponsor-initiated suspension to halt enrollment. Subjects that were enrolled were followed to completion. Last Subject Last Visit occurred on 20-Oct-2025.
United States25 participantsStarted 2022-05-06
Plain-language 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.
Who can participate
Age range
22 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of complete angiographic occlusion without significant stenosis, and no rebleeding or retreatment of the target aneurysm
Timeframe: at 365-day
2
Incidence of neurological death or disabling stroke post-procedure.
. 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.
. 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.