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

被引：21

作者：

Pereira, Vitor Mendes ^{[1
,12
]}

Rice, Hal ^{[2
]}

De Villiers, Laetitia ^{[2
]}

Sourour, Nader ^{[3
]}

Clarencon, Frederic ^{[3
]}

Spears, Julian ^{[1
]}

Tomasello, Alejandro ^{[4
]}

Hernandez, David ^{[4
]}

Cancelliere, Nicole M. ^{[1
]}

Liu, Xiao Yu Eileen ^{[1
]}

Nicholson, Patrick ^{[5
]}

Costalat, Vincent ^{[6
]}

Gascou, Gregory ^{[6
]}

Mordasini, Pasquale ^{[7
]}

Gralla, Jan ^{[7
]}

Martinez-Galdamez, Mario ^{[8
]}

Galvan Fernandez, Jorge ^{[8
]}

Killer-Oberpfalzer, Monika ^{[9
]}

Turner, Raymond D. ^{[10
]}

Blanc, Raphael ^{[11
]}

Piotin, Michel ^{[11
]}

机构：

[1] Univ Toronto, St Michaels Hosp, Dept Surg, Div Neurosurg, Toronto, ON, Canada

[2] Gold Coast Univ Hosp, Dept Neurointervent, Southport, Qld, Australia

[3] Hop Univ Pitie Salpetriere, Dept Intervent Neuroradiol, Paris, France

[4] Hosp Valle De Hebron, Dept Neurointervent, Barcelona, Catalunya, Spain

[5] Toronto Western Hosp, Dept Med Imaging, Toronto, ON, Canada

[6] Ctr Hosp Univ Montpellier, Dept Neuroradiol, Montpellier, France

[7] Inselspital Univ Spital Bern, Dept Diagnost & Intervent Neuroradiol, Bern, Switzerland

[8] Hosp Clin Univ Valladolid, Dept Intervent Neuroradiol & Endovasc Neurosurg, Valladolid, Spain

[9] Paracelsus Med Univ, Dept Neurosurg, Salzburg, Austria

[10] Prisma Hlth, Div Neurosurg, Greenville, SC USA

[11] Fdn Adolphe De Rothschild, Dept Intervent Neuroradiol, Paris, France

[12] St Michaels Hosp, Dept Neurosurg, Director Endovasc Res & Innovat, Toronto, ON, Canada

来源：

JOURNAL OF NEUROINTERVENTIONAL SURGERY | 2024年 / 16卷 / 04期

关键词：

Aneurysm; Brain; Coil; Stent; Technology; UNRUPTURED INTRACRANIAL ANEURYSMS; PERCUTANEOUS CORONARY INTERVENTION; RISK-FACTORS; FEASIBILITY; EXPOSURE; OUTCOMES; THERAPY; TRIAL;

D O I：

10.1136/jnis-2023-020161

中图分类号：

R445 [影像诊断学];

学科分类号：

100207 ;

摘要：

BackgroundRobotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases.ObjectiveTo evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms.MethodsThis 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.ResultsThe 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.ConclusionsThis 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 numberNCT04236856

引用

页码：405 / 411

页数：8

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