Background: Wide-necked intracranial aneurysms present unique challenges for endovascular treatment. The Comaneci device is a novel temporary bridging device designed to assist coil embolization without parent vessel occlusion.

Methods: The SUccess in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS) was a multicenter, prospective, postmarket surveillance study conducted at 17 US centers. Ninety consecutive patients with wide-necked intracranial aneurysms were treated with Comaneci-assisted coiling. The primary effectiveness endpoint was successful aneurysm occlusion (Raymond-Roy class I/II) at procedure end. Primary safety endpoints included periprocedural events within 24 hours and clinical outcomes at discharge and 30 days.

Results: Of 90 enrolled patients (mean age 63 years, 63% female), 32 (36%) presented with ruptured aneurysms. Most common locations were anterior communicating (33%), internal carotid (20%), and posterior communicating arteries (19%). Successful occlusion was achieved in 85.6% of cases at procedure end and 94.7% at 6 months. Good clinical outcome (modified Rankin Scale (mRS) 0-2) was maintained from baseline (73%) through 30 days (81%) and 6 months (83%). Thromboembolic events occurred in 5.5% of cases, all asymptomatic. Device-related complications were minimal, with coil entanglement in 0.3% of deployed coils and no instances of deployment/retrieval failure. All-cause mortality was 4.4%, confined to the ruptured aneurysm cohort.

Conclusions: The SUCCESS study demonstrates high rates of successful aneurysm occlusion with Comaneci-assisted coiling, with occlusion rates persisting through 6 month follow-up. The safety profile was favorable, with low rates of thromboembolic events compared with other assist techniques. These results support the use of the Comaneci device for wide-necked aneurysm treatment in both ruptured and unruptured settings.

Trial registration number: NCT04518670.