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 range22 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. 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.
âś“. Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device.
✓. Subject is ≥ 22 and ≤ 80 years of age.
âś“. Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3.
âś“. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent.
Exclusion criteria
✕. Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device.
âś•. 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.
âś•. Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device.
âś•. Subject with intraparenchymal hemorrhage.
âś•. Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement.
âś•. Subject has a pre-morbid mRS \>2.
âś•
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 requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm.
âś•. 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.