Ruptured Aneurysm
Conditions
Brief summary
Comparison of efficacy and safety between WEB and other endovascular techniques
Interventions
OTHERRandomisation
Technique assigned through randomization
Sponsors
Microvention-Terumo, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| As exploratory design, one of the outcome will be the assessment of aneurysm occlusion at 12 months using Raymond-Roy scale. | 12 months (-3/+6 months) | Raymond-Roy Classification is an angiographic classification including 3 classes, from class 1 (complete obliteration) to class 3 (aneurysm remnant). |
Countries
France
Contacts
Primary ContactClinical Department
Outcome results
None listed