CorPath® GRX Neuro Study

NCT04236856 | Completed Results DMC

• 1 other identifier: 104-08660
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 9

Brief Summary

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.

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage; Headache

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Robotically Navigate Device to the Target Aneurysm

  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

  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

  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

  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

  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.

Study Arms (1)

Robotic Endovascular Procedure

OTHER

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

Interventions

Robotic Endovascular Procedure DEVICE

After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.

Also known as: CorPath GRX System

Robotic Endovascular Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (10)

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Uniklinikum Salzburg

Salzburg, Austria

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

St. Michael's Hospital

Toronto, Canada

Location

Hôpital Pitié-Salpêtrière

Paris, CA, 75013, France

Location

CHU Montpellier - Hôpital Gui de Chauliac

Montpellier, France

Location

Hôpital de la Fondation Rothschild

Paris, 75940, France

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

University Clinical Hospital of Valladolid

Valladolid, 47003, Spain

Location

Inselspital, Universitätsspital Bern

Bern, Switzerland

Location

Related Publications (6)

• Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.

  PMID: 28723321 BACKGROUND

• 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.

  PMID: 26330064 BACKGROUND

• 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.

  PMID: 22556195 BACKGROUND

• 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.

  PMID: 23406828 BACKGROUND

• Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.

  PMID: 18523626 BACKGROUND

• 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, Martinez-Galdamez M, Galvan Fernandez J, Killer-Oberpfalzer M, Liebeskind DS, Turner RD, Blanc R, Piotin M. Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms. J Neurointerv Surg. 2024 Mar 14;16(4):405-411. doi: 10.1136/jnis-2023-020161.

  PMID: 37793795 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage; Headache

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Clinical Scientist
• Organization: Corindus

hamid.rai@siemens-healthineers.com

6173012445

Study Officials

• Michel Piotin, MD, PhD

  Interventional Neuroradiologisit & Director, Foundation Rothschild

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 22, 2020
• Study Start: August 21, 2020
• Primary Completion: April 23, 2022
• Study Completion: October 12, 2022
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CH (1); CA (2); FR (3); ES (2)