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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Yale New Haven Hospital
New Haven, Connecticut, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kentucky Albert B Chandler Hospital
Lexington, Kentucky, United States
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
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Stony Brook University Hospital
Stony Brook, New York, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Semmes Murphey Clinic
Memphis, Tennessee, United States
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