EESIS-FR. French eCLIPs™ Efficacy and Safety Investigation of eCLIPs devices for intracranial Bifurcation Aneurysms. Mid Enrolment results.

Abstract

Introduction and Methods

eCLIPs eB is a unique device designed to retain coils and divert flow at a bifurcation aneurysm with 4 sizes to accommodate neck lengths to 12mm. French eCLIPs™ Efficacy and Safety Investigation (EESIS-FR) is an open label, prospective, historically controlled (vs. optimal performance criteria), multicentre, single-arm study trial partly funded by French HAS under its Forfait Innovation program to demonstrate safety and efficacy of eCLIPs for saccular, intracranial aneurysms, unruptured or previously ruptured (≥1 month since rupture and neurologically stable), arising at a bifurcation of Basilar Tip (BT) or Carotid Terminus (CT), with a minimal diameter of 5mm and a maximal diameter <25mm, has a neck length of ≥4mm or dome:neck ratio <2, branch artery diameters in the range of 1.5mm to 3.25mm.

Results

We report the first 60 patients (of a goal of 119) enrolled at 13 sites (opened on 26 particpating sites). Aneurysm characteristics: 26 BT, 34 CT, 15 recurrent after prior treatment, 9 previously ruptured. Aneurysm metrics are as follows (Table1):

Safety

Two patients (3.3%) had procedural safety events: one had small subarachnoid hemorrhage (microcatheter manipulation) at the bifurcation and 1 had spinal ischemia due to access-catheter trauma to vertebral artery. Thirty-eight patients have follow-up at 6 months, 11 patients ≥12 months. No subsequent safety events occurred through follow-up; only 1 patient (noted above) had MRS >2.

Efficacy

modified Raymond Roy Occlusion Classification (mRROC) at each follow-up:

Conclusion

EESIS-FR is the first prospective analysis of eCLIPs eB, showing in preliminary results acceptable safety and efficacy profiles. The complete results of the full cohort of 119 patients are necessary to finalize these conclusions.