This is a multicentre post marketing study in France evaluating the safety and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms at the carotid and basilar terminus. The eCLIPs device is the first neuro device that has gained Innovation funding (in French, “Forfait innovation”) from French National Authority for Health (Haute Autorité de santé – HAS).
ID: NCT05330897
Last Publication: French eCLIPs™ Efficacy and Safety Investigation of eCLIPs devices for intracranial Bifurcation Aneurysms. Mid Enrolment results | CERC
Sponsor
Primary endpoints
- Efficacy Endpoint: Proportion of patients with aneurysms with complete occlusion (Raymond-Roy score 1) with no recurrence or re-treatment at 12 months.
- Safety Endpoint: Proportion of patients with a major stroke or non-accidental death within 30 days (procedural) or with a major ipsilateral stroke or neurological death between 31 days and 12 months.
CERC Services
- Study documents draft and review
- Project management
- Sites' contract management
- EDC and data management
- Monitoring activities
- Safety reporting
- CEC and DSMB activities
- Final study report
Countries
France
Number of investigational sites
28
Number of patients
119 patients expected
