European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.
NCT ID: NCT06511245
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-02
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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WEB
Randomisation
Technique assigned through randomization
Other endovascular techniques
Randomisation
Technique assigned through randomization
Interventions
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Randomisation
Technique assigned through randomization
Eligibility Criteria
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Inclusion Criteria
* Patient has an identified acutely ruptured intracranial aneurysm requiring endovascular treatment (for the purposes of this study an acutely ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days)
* Aneurysm dome diameter must be ≤ 10mm and within the diameter (and parent vessel diameter, as appropriate) range treatable by commercially available WEB devices as well as at least one other alternative commercially available endovascular treatment device used per hospital standard practice
* Aneurysm is located on the anterior communicating artery complex segment (ACom), internal carotid artery terminus (ICAt), anterior cerebral artery (ACA), middle cerebral artery (MCA), basilar apex, posterior communicating artery (PCom) or pericallosal artery
* Patient must be neurologically stable with a Hunt \& Hess score of I to III
* Patient or patient's legally authorized representative (LAR) has provided written informed consent
Exclusion Criteria
* Patient presenting as target aneurysm a blister like or dissecting aneurysm
* Patient has more than one aneurysm requiring treatment within 30 days of completion of treatment of the target aneurysm
* Patient with multiple aneurysms in whom ruptured aneurysm cannot be identified
* Patient has pre-morbid mRS \> 2
18 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Locations
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CHU Reims
Reims, , France
Countries
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Central Contacts
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Other Identifiers
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CIP EMEA 23-01
Identifier Type: OTHER
Identifier Source: secondary_id
CIP EMEA 23-01
Identifier Type: -
Identifier Source: org_study_id