Brain Aneurysm
Conditions
Brief summary
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.
Detailed description
All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled. Subjects will be followed per Institution's standard of care.
Interventions
Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.
Sponsors
Microvention-Terumo, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must be ≥ 18 years of age and ≤80 years of age 2. Subject must have an intracranial aneurysm (IA), 3. Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection 4. For ruptured aneurysm, Subject with Hunt & Hess Score ≤ III
Exclusion criteria
1. Subject has an IA with characteristics unsuitable for endovascular treatment 2. Subject's index IA was previously treated 3. Subject has stroke-in-evolution within the prior 30 days 4. An additional aneurysm must be treated during the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm occlusion | 12 months | Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. * class I: complete obliteration * class II: residual neck * class III: residual aneurysm |
| Incidence of major stroke or neurological deaths | 12months | The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment |
Countries
France, Germany, Hungary
Outcome results
None listed