O17/171 World’s first robotic assisted cerebral aneurysm embolization international trial

医学 神经血管束 动脉瘤 栓塞 颈内动脉 临床试验 外科 放射科 内科学
作者
Vítor Mendes Pereira,Hal Rice,Laetitia de Villiers,Nader Sourour,Frédéric Clarençon,Julian Spears,Alejandro Tomasello,Marc Ribó,Vincent Costalat,Grégory Gascou,Pasquale Mordasini,Jan Gralla,Mario Martinez Galdamez,Jorge Galván‐Fernández,Monika Killer‐Oberpfalzer,Raymond Turner,Raphaël Blanc,Michel Piotin
出处
期刊:Abstracts 卷期号:: A9.2-A10
标识
DOI:10.1136/jnis-2023-esmint.17
摘要

Introduction

Robotic assisted neurointervention is a recently available technology with exciting future applications in the treatment of neurovascular diseases.

Aim of Study

To evaluate the effectiveness and safety of robotic platform Corpath GRX (Siemens Healthineers Endovascular Robotics, Newton, MA, USA) for treating cerebral aneurysms alongside 6 months clinical follow-up.

Methods

This prospective, international, multi-center study enrolled patients with clinical indication for endovascular coil and/or stent-assist coiling embolization. The primary effectiveness was defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual. An independent clinical evaluation committee assessed outcomes gathered over the course of six months post-procedure.

Results

The study enrolled 117 patients among 10 international sites, with mean age of 56.6 years and 74.4% females. Headache was the most common presenting symptom in 34.2% subjects. Internal Carotid Artery was the most common location (27.9%) and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm respectively. Primary effectiveness was achieved in 94% (110/117) subjects with seven subjects requiring conversion to manual procedure. Only 4 primary safety events were recorded with 2 intraprocedural aneurysm ruptures and 2 minor strokes. Raymond Roy Classification Scale of 1 was achieved in 94.1% (96/102) subjects at 6 months follow-up, with mRS of ≤2 for 98.9% (87/88) subjects.

Conclusion

This trial affirms the efficacy and safety of robotic-assisted cerebral aneurysm treatments, and serves as a steppingstone towards the potential future application of building on the current technological platform for achieving the goal of remote thrombectomy.

Disclosure of Interest

Vitor Mendes Pereira : Siemens Hal Rice : NOD Laetitia Villiers : NOD Nader Sourour : Balt, Medtronic, Radical Frédéric Clarençon : Artedrone, Stryker, Balt, Medtronic, Intradys Julian Spears : NOD Alejandro Tomasello : NOD Marc Ribo : NOD Vincent Costalat : NOD Gregory Gascou : NOD Pasquale Mordasini : Siemens Jan Gralla : Siemens Mario Martinez Galdamez : NOD Jorge Galván-Fernández : NOD Monika Killer-Oberpfalzer : Siemens Raymond Turner : Medtronic,Microvention,Q'Apel,Integra,Siemens,Endostream,E8,New View Surgical,Viseon Raphael Blanc : Basecamp Vascular BCV Michel Piotin : NOD
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