Insights from the EESIS-FR trial and safety profiles
Launched in 2021 across 18 French centers, the prospective EESIS-FR trial evaluated 123 patients presenting with wide-neck bifurcation aneurysms (neck greater than 4mm, mean size over 5mm) located at the carotid terminus (60%) and basilar tip (40%), all deemed untreatable by open surgery. Patients underwent implantation of the eCLIPs™ device combined with adjunct coiling.
While the neurointerventional community awaits the definitive one-year data, immediate one-month safety outcomes published in JNIS demonstrate that eCLIPs™ compares favorably against standard stenting techniques:
- High technical feasibility: Operators achieved a 95% implantation success rate, supported by structured proctoring.
- Favorable safety profile: The study recorded low mortality rates, well below literature benchmarks for complex stenting.
- No device-related injuries: Despite the unique deployment technique requiring a "pushing" maneuver similar to a stent retriever, the laser-cut construct proved highly supple. No vessel perforations, ischemic events, or hemorrhagic complications occurred during deployment.
Distal Evolutions and Intrasacular Recurrences
Beyond the EESIS-FR cohort, the global eCLIPs™ registry is expanding into challenging MCA and ACOM locations. While navigating these areas is anatomically complex due to outflow branches, smaller iterations are facilitating access. The current smallest version delivers via a 21 microcatheter, allowing operators to safely navigate distal territories and achieve definitive aneurysm cure in complex anatomies.
Furthermore, Waleed Butt highlighted the device's great performance in treating post-procedural recurrences of intrasacular devices. These shallow, wide-neck recurrences typically demand risky configurations like Y-stenting or T-stenting. The eCLIPs™ device provides complete neck bridging and adequate metal coverage without requiring multiple stents, allowing safe secondary coiling.
