About this trial
Comparison of efficacy and safety between WEB and other endovascular techniques
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Randomisation
Other interventionTechnique assigned through randomization
Treatment groups
Trial outcomes
Primary outcomes
As exploratory design, one of the outcome will be the assessment of aneurysm occlusion at 12 months using Raymond-Roy scale.
Raymond-Roy Classification is an angiographic classification including 3 classes, from class 1 (complete obliteration) to class 3 (aneurysm remnant).
Sponsors and contacts
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