CLEVER Study:
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
WEB™ Intrasaccular Embolization
"Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up."
- Patients
163
- Countries
Germany, France, Finland, UK, Hungary
- Clinical Centers
17
- Design
Single arm prospective
- Scope
Patients 18-80 y.o.with bifurcation intracranial aneurysls, ruptured or unruptured, H&H<4, eligible to be treated with WEB 17.
- Purpose
Assessment of efficacy and safety of WEB 17.
Endpoints
Efficacy:
Adequate occlusion without retreatment at 12 months (assessed by Corelab)
Safety:
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
Efficacy results
Primary endpoint:
Adequate occlusion without retreatment at 12 months: 82.2% (84.9% for rupt AN and 80.6% for unrupt AN)
At 12 months:
Adequate occlusion: 83.9% (86.5% for ruptured AN and 82.4% for unrupt AN)
Complete occlusion: 62.9% (73.1% for rupt AN and 57.1% for unrupt AN)
Retreatment rate: 2.6%
Safety results
Primary endpoint:
Death of non-accidental cause or major stroke within 30 days or major ipsilateral stroke or death of neurological cause from day 31 to 1 year: 1.8% (3.3% for rupt AN and 1.0% for unrupt AN)
At 1 month:
Overall morbidity: 5.7%
Overall mortality: 0%
At 12 months:
Major stroke: 1.8%
Overall morbidity: 2.0% (0% device-related)
Overall mortality: 0.6% (0% device-related)
Study publications
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT03844334
Please refer to Instruction for Use (IFU) in the specific market/country that you are looking into:
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