Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms.

Mendes Pereira, Vitor; Rice, Hal; De Villiers, Laetitia; Sourour, Nader; Clarencon, Frédéric; Spears, Julian; Tomasello, Alejandro; Hernandez, David; Cancelliere, Nicole M; Liu, Xiao Yu Eileen; Nicholson, Patrick; Costalat, Vincent; Gascou, Gregory; Mordasini, Pasquale; Gralla, Jan; Martínez-Galdámez, Mario; Galvan Fernandez, Jorge; Killer-Oberpfalzer, Monika; Turner, Raymond D; Blanc, Raphael; ... (2024). Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms. Journal of neurointerventional surgery, 16(4), pp. 405-411. BMJ Publishing Group 10.1136/jnis-2023-020161

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BACKGROUND

Robotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases.

OBJECTIVE

To evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms.

METHODS

This prospective, international, multicenter study enrolled patients with brain aneurysms that required endovascular coiling and/or stent-assisted coiling. The primary effectiveness endpoint was defined as successful completion of the robotic-assisted endovascular procedure without any unplanned conversion to manual treatment with guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. The primary safety endpoint included intraprocedural and periprocedural events.

RESULTS

The study enrolled 117 patients (74.4% female) with mean age of 56.6 years from 10 international sites,. Headache was the most common presenting symptom in 40/117 (34.2%) subjects. Internal carotid artery was the most common location (34/122, 27.9%), and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm, respectively. The overall procedure time was 117.3±47.3 min with 59.4±32.6 min robotic procedure time. Primary effectiveness was achieved in 110/117 (94%) subjects with seven subjects requiring conversion to manual for procedure completion. Only four primary safety events were recorded with two intraprocedural aneurysm ruptures and two strokes. A Raymond-Roy Classification Scale score of 1 was achieved in 71/110 (64.5%) subjects, and all subjects were discharged with a modified Rankin Scale score of ≤2.

CONCLUSIONS

This first-of-its-kind robotic-assisted neurovascular trial demonstrates the effectiveness and safety of the CorPath GRX System for endovascular embolization of cerebral aneurysm procedures.

TRIAL REGISTRATION NUMBER

NCT04236856.

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6 Citations in Scopus

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