CorPath® GRX Neuro Study

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

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.

Study Overview

• Status: Completed
• Conditions: Headache; Subarachnoid Hemorrhage; Intracranial Aneurysm
• Intervention / Treatment: Device: Robotic Endovascular Procedure

Detailed 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. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
• Austria
  • Salzburg, Austria
    • Uniklinikum Salzburg
• Canada
  • Toronto, Canada
    • St. Michael's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
• France
  • Montpellier, France
    • CHU Montpellier - Hôpital Gui de Chauliac
  • Paris, France, 75940
    • Hôpital de la Fondation Rothschild
  • CA
    • Paris, CA, France, 75013
      • Hopital Pitie-Salpetriere
• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron University Hospital
  • Valladolid, Spain, 47003
    • University Clinical Hospital of Valladolid
• Switzerland
  • Bern, Switzerland
    • Inselspital, Universitätsspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio >1.5 or aneurysm neck width >4.0 mm.
3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.
2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
3. Women who are pregnant.
4. Persons under guardianship or curatorship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Robotic Endovascular Procedure; 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; After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.; Other Names: CorPath GRX System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 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.
Number of Intra- 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, whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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.
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.
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.
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.
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.
Number of 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 (180-days following the robotic-assisted procedure).
Number of Participants With Aneurysm Occlusion	Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory. Raymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.	Assessed at 180 Day Follow-up
Number of Participants With Aneurysm Occlusion	Angiographic assessment of aneurysm occlusion grade according to the Raymond-Roy Occlusion Classification Scale, parent-vessel compromise, and occlusion durability as assessed from an independent core laboratory. Raymond Roy Occlusion Classification Scale - Minimum:1, Maximum: 3b, Higher score meaning worse outcome.	Assessed During Procedure (Post Intervention)

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Investigators: Principal Investigator: Michel Piotin, MD, PhD, Interventional Neuroradiologisit & Director, Foundation Rothschild

Publications and helpful links

General Publications

• Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.
• Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.
• Lantigua H, Ortega-Gutierrez S, Schmidt JM, Lee K, Badjatia N, Agarwal S, Claassen J, Connolly ES, Mayer SA. Subarachnoid hemorrhage: who dies, and why? Crit Care. 2015 Aug 31;19(1):309. doi: 10.1186/s13054-015-1036-0.
• Steiner T, Juvela S, Unterberg A, Jung C, Forsting M, Rinkel G; European Stroke Organization. European Stroke Organization guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage. Cerebrovasc Dis. 2013;35(2):93-112. doi: 10.1159/000346087. Epub 2013 Feb 7.
• Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Actual): April 23, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Arterial Diseases; Intracranial Hemorrhages; Headache; Aneurysm; Hemorrhage; Subarachnoid Hemorrhage; Intracranial Aneurysm
• Other Study ID Numbers: 104-08660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No