CorPath® GRX Neuro Study

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.

Detailed Description
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This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.

Official Title
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An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms

Conditions
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Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache

Intervention / Treatment
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* Device: Robotic Endovascular Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio >1.5 or aneurysm neck width >4.0 mm. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment. Women who are pregnant. Persons under guardianship or curatorship.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Robotic Endovascular Procedure<br>Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System. | Device: Robotic Endovascular Procedure<br>* After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.<br>* Other names: CorPath GRX System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Technical Success. | The primary effectiveness endpoint will be defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. | Measured from the start of the procedure to the end of the procedure. | 
| Incidence of Inta- and Peri-procedural Events. | The primary safety endpoint will be a composite of intra- and periprocedural events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24-hours post- procedure or hospital discharge, whichever occurs first. | Measured from the start of the procedure through 24 hours or discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Robotically Navigate Device to the Target Aneurysm | Defined as successful advancement of device to the target aneurysm robotically. | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will also undergo clinical follow-up through 180 days. | 
| Robotically Navigate Device into the Target Aneurysm | Defined as successful navigation of device into the target aneurysm robotically | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will also undergo clinical follow-up through 180 days. | 
| Robotically Deploy Therapeutic Device into the Target Aneurysm | Defined as successful deployment of therapeutic device into the target aneurysm robotically | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will also undergo clinical follow-up through 180 days. | 
| Overall Procedure Time | Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will also undergo clinical follow-up through 180 days. | 
| Fluoroscopy Time | Total fluoroscopy utilized during the procedure as recorded by the Imaging System | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will also undergo clinical follow-up through 180 days. | 
| Patient Radiation Exposure | DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will also undergo clinical follow-up through 180 days. | 
| Contrast Fluid Volume | Total contrast used during the procedure | Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will also undergo clinical follow-up through 180 days. | 
| Adverse Events | All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized; | Measured from the start of the procedure through end of the study. Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will undergo clinical follow-up th | 
| Thromboembolic Events | Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure | Measured from the start of the procedure through end of the study. Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will undergo clinical follow-up th | 
| Devices Used Robotically | Recorded as successful or unsuccessful in conjunction with the CorPath GRX System | Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day | 
| Aneurysm Occlusion | Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy classification scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory. | Assessed post-procedure and at a 180-day follow-up. |