The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.
This study is a multicentre, open label, historically controlled, single-arm safety and efficacy study of the eCLIPs™ products in the management of bifurcated intracranial aneurysms at basilar tip and carotid terminus. Patients with basilar tip and carotid terminus aneurysms are not considered suitable for surgical treatment by the neurovascular community because of the poor outcome in these localizations. Patients included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation, having a neck length of ≥ 4mm or have a dome:neck ratio \<2. Efficacy will be measured as the proportion of aneurysms achieving complete occlusion (Raymond-Roy 1) at 12 months, while safety will be measured as the proportion of patients without a major stroke or non-accidental death within 30 days (procedural) and without a major ipsilateral stroke or neurological death between 31 days and 12 months. Additional endpoints will be evaluated and data collected to assess safety and collect information on the eCLIPs™ family of products.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm
Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm
CHU d'Amiens
Amiens, France
Complete aneurysm occlusion with no recurrence or re-treatment
Percent of subjects with complete aneurysm occlusion with no recurrence or re-treatment
Time frame: 12 months
Major stroke or non-accidental death within 30 days, or major ipsilateral stroke or neurological death between 31 days and 12 months
Percent of subjects with a major stroke or non-accidental death within 30 days or with a major ipsilateral stroke or neurological death between 31 days and 12 months
Time frame: 12 months
Technical success
Proportion of successful eCLIPs™ device implants at the target aneurysm
Time frame: Immediately after the procedure
Complete aneurysm occlusion
Percent of subjects with complete aneurysm occlusion at 6 and 24 months
Time frame: 24 months
Complete and nearly complete aneurysm occlusion
Percent of subjects with complete and nearly complete aneurysm occlusion at 6, 12 and 24 months
Time frame: 24 months
Major ipsilateral stroke or neurological death
Percent of subjects with a major ipsilateral stroke or neurological death
Time frame: 24 months
Success of adjuvant coiling into aneurysm after successful eCLIPs™ implant
Proportion of subjects with procedural success for the ability to insert coils into the aneurysm beyond the successfully implanted eCLIPs™ device, and the eCLIPs™ device to satisfactorily retain coils
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Groupe Hospitalier Pellegrin
Bordeaux, France
CHRU de Brest - Hôpital Cavale Blanche
Brest, France
HCL - Hôpital Pierre Wertheimer
Bron, France
CHU de Caen Normandie
Caen, France
Hôpital Gabriel Montpied
Clermont-Ferrand, France
CH de Colmar - Hôpital Louis Pasteur
Colmar, France
Clinique des Cèdres
Cornebarrieu, France
AP-HP - HU Henri-Mondor
Créteil, France
Hôpital François Mitterrand
Dijon, France
...and 18 more locations
Time frame: Immediately after the procedure
Modified Rankin Score
Percent of subjects experiencing deterioration of Rankin Score from baseline to 1 month, 6-month, 12-month, and 24-month follow-up
Time frame: 24 months
Serious Adverse Device Effects
Percent of subjects experiencing Serious Adverse Device Effects at 1, 6, 12 and 24 months
Time frame: 24 months
Unplanned aneurysm re-treatment
Percent of subjects having an unplanned aneurysm re-treatment within 12 or 24 months
Time frame: 24 months
Device migration
Proportion of device migration at 12 and 24 months
Time frame: 24 months
Artery stenosis
Measurement of artery stenosis by radiography at 6, 12 and 24 months
Time frame: 24 months
Artery patency
Qualitative assessment of artery patency at 6, 12 and 24 months
Time frame: 24 months