Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CorPath® GRX Neuro Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236856
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.

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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Subarachnoid Hemorrhage Headache Device: Robotic Endovascular Procedure Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
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 Name: CorPath GRX System




Primary Outcome Measures :
  1. 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. Incidence of Inta- and Peri-procedural Events. [ Time Frame: Measured from the start of the procedure through 24 hours or discharge. ]
    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 Outcome Measures :
  1. Robotically Navigate Device to the Target Aneurysm [ Time Frame: 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 Navigate Device into the Target Aneurysm [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Defined as successful navigation of device into the target aneurysm robotically

  3. Robotically Deploy Therapeutic Device into the Target Aneurysm [ Time Frame: 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

  4. Overall Procedure Time [ Time Frame: 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

  5. Fluoroscopy Time [ Time Frame: 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

  6. Patient Radiation Exposure [ Time Frame: 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

  7. Contrast Fluid Volume [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Total contrast used during the procedure

  8. Adverse Events [ Time Frame: Measured from the start of the procedure through 24 hours or discharge. ]
    All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Failure/inability/unwillingness to provide informed consent.
  2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236856


Contacts
Layout table for location contacts
Contact: Tina M Ridgeway, BS, RN 7578105166 tina.ridgeway@corindus.com
Contact: John Van Vleet 2066158892 john.vanvleet@corindus.com

Locations
Layout table for location information
France
Hôpital de la Fondation Rothschild
Paris, France, 75940
Principal Investigator: Michel Piotin, MD         
Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Corindus Inc.
Investigators
Layout table for investigator information
Principal Investigator: Michel Piotin, MD, PhD Interventional Neuroradiologisit & Director, Foundation Rothschild

Publications:
Layout table for additonal information
Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT04236856    
Other Study ID Numbers: 104-08660
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD.

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Subarachnoid Hemorrhage
Intracranial Aneurysm
Aneurysm
Hemorrhage
Headache
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases