Recruiting NCT06511245
European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Randomisation.
- Who it may be relevant to
- Registry conditions: Ruptured Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
WEB™ Embolization System in the Treatment of Acutely Ruptured Intracranial Aneurysms Versus Other Endovascular Techniques
Overview
Comparison of efficacy and safety between WEB and other endovascular techniques
Interventions
- Other Randomisation
Technique assigned through randomization
Primary outcome measures
- As exploratory design, one of the outcome will be the assessment of aneurysm occlusion at 12 months using Raymond-Roy scale. [Time frame: 12 months (-3/+6 months)]
Eligibility criteria
Main 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
Main 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Reims — Reims
Identifiers
NCT: NCT06511245 · CIP EMEA 23-01 · CIP EMEA 23-01