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RECRUITINGNA

European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.

WEB™ Embolization System in the Treatment of Acutely Ruptured Intracranial Aneurysms Versus Other Endovascular Techniques

NCT06511245•Microvention-Terumo, Inc.

View on ClinicalTrials.gov

Summary

Comparison of efficacy and safety between WEB and other endovascular techniques

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is above 18 years of age at the time of consent
•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

•Aneurysm to be treated is unsuitable for endovascular treatment with commercially available WEB devices and/or all other available endovascular treatment techniques used per standard site practice
•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

Locations (1)

CHU Reims

Reims, France

Key Dates

Start Date

October 2, 2024

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2027

Last Updated

December 18, 2024

Enrollment

ESTIMATED participants

Conditions

Ruptured Aneurysm

Interventions

Randomisation

OTHER

Contacts

Clinical Department

CONTACT

+33(0)139217746 MVEClinicalEMEA@microvention.com

EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)

NCT04391803

Intracranial AneurysmRuptured Aneurysm

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NOT_YET_RECRUITINGPHASE2

Efficacy of Daily IV Administration of Dornase Alfa Up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence At 6 Months

NCT06723717

Ruptured Aneurysm of Intracranial ArterySAH (Subarachnoid Hemorrhage)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.

Inclusion Criteria

Exclusion Criteria

EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)

Efficacy of Daily IV Administration of Dornase Alfa Up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence At 6 Months

Matrix Metalloproteinases (MMPs),Neutrophil Gelatinase-associated Lipocalin (NGAL) Tissue and Plasma Levels and Aneurysms