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

Vitor Mendes Pereira; Hal Rice; Laetitia De Villiers; Nader Sourour; Frédéric Clarencon; Julian Spears; Alejandro Tomasello; David Hernandez; Nicole M Cancelliere; Xiao Yu Eileen Liu; Patrick Nicholson; Vincent Costalat; Gregory Gascou; Pasquale Mordasini; Jan Gralla; Mario Martínez-Galdámez; Jorge Galvan Fernandez; Monika Killer-Oberpfalzer; David S Liebeskind; Raymond D Turner; Raphael Blanc; Michel Piotin

doi:10.1136/jnis-2023-020161

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

Vitor Mendes Pereira, Hal Rice, Laetitia De Villiers, Nader Sourour, Frédéric Clarencon, Julian Spears, Alejandro Tomasello, David Hernandez, Nicole M Cancelliere, Xiao Yu Eileen Liu, Patrick Nicholson, Vincent Costalat, Gregory Gascou, Pasquale Mordasini, Jan Gralla, Mario Martínez-Galdámez, Jorge Galvan Fernandez, Monika Killer-Oberpfalzer (Co-author), David S Liebeskind, Raymond D TurnerRaphael Blanc, Michel Piotin

Department of Neurology

St. Michael’s Hospital, Canada Diagnostic and Therapeutic Neuroradiology University of Toronto Tom R. Marotta, MD, FRCPC, Assistant Professor

Research output: Contribution to journal › Original Article › peer-review

Abstract

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.

Original language	English
Number of pages	8
Journal	JOURNAL OF NEUROINTERVENTIONAL SURGERY
Early online date	Oct 2023
DOIs	https://doi.org/10.1136/jnis-2023-020161
Publication status	Published - 3 Oct 2023

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Mendes Pereira, V., Rice, H., De Villiers, L., Sourour, N., Clarencon, F., Spears, J., Tomasello, A., Hernandez, D., Cancelliere, N. M., Liu, X. Y. E., Nicholson, P., Costalat, V., Gascou, G., Mordasini, P., Gralla, J., Martínez-Galdámez, M., Galvan Fernandez, J., Killer-Oberpfalzer, M., Liebeskind, D. S., ... Piotin, M. (2023). Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms. JOURNAL OF NEUROINTERVENTIONAL SURGERY. https://doi.org/10.1136/jnis-2023-020161

@article{c28baf41085c4f6fb2a10b9026483ea7,

title = "Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms",

abstract = "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.",

author = "{Mendes Pereira}, Vitor and Hal Rice and {De Villiers}, Laetitia and Nader Sourour and Fr{\'e}d{\'e}ric Clarencon and Julian Spears and Alejandro Tomasello and David Hernandez and Cancelliere, {Nicole M} and Liu, {Xiao Yu Eileen} and Patrick Nicholson and Vincent Costalat and Gregory Gascou and Pasquale Mordasini and Jan Gralla and Mario Mart{\'i}nez-Gald{\'a}mez and {Galvan Fernandez}, Jorge and Monika Killer-Oberpfalzer and Liebeskind, {David S} and Turner, {Raymond D} and Raphael Blanc and Michel Piotin",

note = "Killer-Oberpfalzer: Department of Neurosurgery, Paracelsus Medical University, Salzburg, Austria",

year = "2023",

month = oct,

day = "3",

doi = "10.1136/jnis-2023-020161",

language = "English",

journal = "JOURNAL OF NEUROINTERVENTIONAL SURGERY",

issn = "1759-8478",

publisher = "Bmj Publishing Group",

}

Mendes Pereira, V, Rice, H, De Villiers, L, Sourour, N, Clarencon, F, Spears, J, Tomasello, A, Hernandez, D, Cancelliere, NM, Liu, XYE, Nicholson, P, Costalat, V, Gascou, G, Mordasini, P, Gralla, J, Martínez-Galdámez, M, Galvan Fernandez, J, Killer-Oberpfalzer, M, Liebeskind, DS, Turner, RD, Blanc, R & Piotin, M 2023, 'Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms', JOURNAL OF NEUROINTERVENTIONAL SURGERY. https://doi.org/10.1136/jnis-2023-020161

TY - JOUR

T1 - Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms

AU - Mendes Pereira, Vitor

AU - Rice, Hal

AU - De Villiers, Laetitia

AU - Sourour, Nader

AU - Clarencon, Frédéric

AU - Spears, Julian

AU - Tomasello, Alejandro

AU - Hernandez, David

AU - Cancelliere, Nicole M

AU - Liu, Xiao Yu Eileen

AU - Nicholson, Patrick

AU - Costalat, Vincent

AU - Gascou, Gregory

AU - Mordasini, Pasquale

AU - Gralla, Jan

AU - Martínez-Galdámez, Mario

AU - Galvan Fernandez, Jorge

AU - Killer-Oberpfalzer, Monika

AU - Liebeskind, David S

AU - Turner, Raymond D

AU - Blanc, Raphael

AU - Piotin, Michel

N1 - Killer-Oberpfalzer: Department of Neurosurgery, Paracelsus Medical University, Salzburg, Austria

PY - 2023/10/3

Y1 - 2023/10/3

N2 - 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.

AB - 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.

U2 - 10.1136/jnis-2023-020161

DO - 10.1136/jnis-2023-020161

M3 - Original Article

C2 - 37793795

SN - 1759-8478

JO - JOURNAL OF NEUROINTERVENTIONAL SURGERY

JF - JOURNAL OF NEUROINTERVENTIONAL SURGERY

ER -

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

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