Document resource
Background The endovascular clip system (eCLIPs), a unique extra-saccular device for treatment of wide necked bifurcation aneurysms (WNBAs), was evaluated in the French eCLIPs efficacy and safety study (EESIS-FR). This paper summarizes the patient demographics, procedural characteristics, and 30 day adverse event (AE) data.Methods The EESIS-FR trial was a prospective study from 18 centers, enrolling 123 adults with WNBAs at the carotid (CT) and basilar (BT) termini. The study protocol was approved by a central ethics committee, had independent adjudication of AEs by a Clinical Events Committee, and had independent core laboratory adjudication of effectiveness outcomes.Results Mean age was 55.0±1.2 years (19–78 years); 73% were women. 43% and 57% of the aneurysms were located at BT and CT, respectively. Mean neck length was 4.8 mm, neck depth 4.2 mm, dome height 5.4 mm, and dome width 6.3 mm. Successful implantation was achieved in 115 cases (93%). Implant time averaged 36 min. Three primary safety events (2.4%) occurred within the first 30 days, all at the index procedure: subarachnoid hemorrhage (SAH) due to a distal guidewire perforation, death from SAH due to rupture of the aneurysm, and spinal cord infarction caused by an occlusive access catheter. Five minor strokes (4.1%) and three transient ischemic attacks (2.4%) occurred, all of which were procedurals. None of these patients had a modified Rankin Scale score of >2 at 30 days. No patient had further ischemic or hemorrhagic events beyond the periprocedural period to 30 days.Conclusion eCLIPs treated WNBAs at BT and CT, with procedural safety and technical success similar to those with intrasaccular devices.