Brain Aneurysm Clinical Trial
— CLEVEROfficial title:
CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Verified date | January 2024 |
Source | Microvention-Terumo, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 163 |
Est. completion date | August 30, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Bicêtre | Le Kremlin-Bicêtre | |
France | Hôpital Purpan | Toulouse | |
Germany | Universitätsklinikum Knappschaftskrankenhaus | Bochum | |
Hungary | National Institute of Clinical Neurosciences | Budapest |
Lead Sponsor | Collaborator |
---|---|
Microvention-Terumo, Inc. |
France, Germany, Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aneurysm occlusion | 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 |
12 months | |
Primary | Incidence of major stroke or neurological deaths | 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 | 12months |
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