The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.
With this other endoluminal stent/device implantation technique to treat intracranial aneurysms in conjunction with embolic coils, the neurovascular device is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment. The eCLIPs™ device manufactured by Evasc Medical Systems Corp. has a high density 'leaf' which is implanted across the bifurcation aneurysm neck and anchored in one of the branch arteries of the bifurcation and may provide improved bifurcation aneurysm treatment by allowing for a higher packing density of embolic coils implanted behind the eCLIPs™ device and the eCLIPs™ device in combination with embolic coils may reduce the recurrence/retreatment rate by increasing the rate of complete aneurysm occlusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms
University of Alberta Hospital
Edmonton, Alberta, Canada
Saint Michael's Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
eCLIPs Bifurcation Remodelling System Technical Success
The proportion of successful eCLIPs device implants at the target aneurysm.
Time frame: 24 hours
No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.
A major stroke is defined as a new neurological event that persists for \>24 hours and results in a 4 point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
Time frame: 30 day-6 month
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Hôpital de l'Enfant-Jésus
Québec, Canada