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Completed

NCT Number: NCT04236856

CorPath® GRX Neuro Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gold Coast University Hospital, Southport, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic Endovascular Procedure

Device

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

Other names: CorPath GRX System

Primary outcomes

  1. Number of Participants With Procedural Technical Success.

    Time frame: Measured from the start of the procedure to the end of the procedure.

    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.

  2. Number of Intra- and Peri-procedural Events.

    Time frame: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.

    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.

Secondary outcomes

  1. Robotically Navigate Device to the Target Aneurysm

    Time frame: 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.

    Defined as successful advancement of device to the target aneurysm robotically.

  2. Robotically Deploy Therapeutic Device Into the Target Aneurysm

    Time frame: 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.

    Defined as successful deployment of therapeutic device into the target aneurysm robotically

  3. Overall Procedure Time

    Time frame: 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.

    Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter

  4. Fluoroscopy Time

    Time frame: 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.

    Total fluoroscopy utilized during the procedure as recorded by the Imaging System

  5. Patient Radiation Exposure

    Time frame: 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.

    DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure

  6. Contrast Fluid Volume

    Time frame: 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.

    Total contrast used during the procedure

  7. Adverse Events

    Time frame: 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

    All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;

  8. Number of Thromboembolic Events

    Time frame: Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).

    Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure

  9. Devices Used Robotically

    Time frame: Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day

    Recorded as successful or unsuccessful in conjunction with the CorPath GRX System

  10. Number of Participants With Aneurysm Occlusion

    Time frame: Assessed at 180 Day Follow-up

    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.

  11. Number of Participants With Aneurysm Occlusion

    Time frame: Assessed During Procedure (Post Intervention)

    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.

Sponsors and collaborators

Lead sponsor

Siemens Healthineers Endovascular Robotics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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