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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04236856
Registration number
NCT04236856
Ethics application status
Date submitted
2/01/2020
Date registered
22/01/2020
Date last updated
9/05/2023
Titles & IDs
Public title
CorPath® GRX Neuro Study
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Scientific title
An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
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Secondary ID [1]
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104-08660
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysm
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Subarachnoid Hemorrhage
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Headache
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Condition category
Condition code
Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Robotic Endovascular Procedure
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.
Treatment: Devices: Robotic Endovascular Procedure
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Procedural Technical Success.
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Assessment method [1]
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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.
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Timepoint [1]
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Measured from the start of the procedure to the end of the procedure.
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Primary outcome [2]
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Incidence of Inta- and Peri-procedural Events.
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Assessment method [2]
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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.
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Timepoint [2]
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Measured from the start of the procedure through 24 hours or discharge.
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Secondary outcome [1]
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Robotically Navigate Device to the Target Aneurysm
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Assessment method [1]
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Defined as successful advancement of device to the target aneurysm robotically.
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Timepoint [1]
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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.
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Secondary outcome [2]
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Robotically Navigate Device into the Target Aneurysm
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Assessment method [2]
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Defined as successful navigation of device into the target aneurysm robotically
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Timepoint [2]
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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.
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Secondary outcome [3]
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Robotically Deploy Therapeutic Device into the Target Aneurysm
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Assessment method [3]
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Defined as successful deployment of therapeutic device into the target aneurysm robotically
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Timepoint [3]
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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.
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Secondary outcome [4]
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Overall Procedure Time
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Assessment method [4]
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Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter
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Timepoint [4]
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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.
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Secondary outcome [5]
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Fluoroscopy Time
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Assessment method [5]
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Total fluoroscopy utilized during the procedure as recorded by the Imaging System
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Timepoint [5]
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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.
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Secondary outcome [6]
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Patient Radiation Exposure
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Assessment method [6]
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DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure
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Timepoint [6]
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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.
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Secondary outcome [7]
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Contrast Fluid Volume
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Assessment method [7]
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Total contrast used during the procedure
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Timepoint [7]
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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.
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Secondary outcome [8]
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Adverse Events
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Assessment method [8]
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All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;
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Timepoint [8]
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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
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Secondary outcome [9]
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Thromboembolic Events
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Assessment method [9]
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Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure
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Timepoint [9]
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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
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Secondary outcome [10]
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Devices Used Robotically
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Assessment method [10]
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Recorded as successful or unsuccessful in conjunction with the CorPath GRX System
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Timepoint [10]
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Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day
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Secondary outcome [11]
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Aneurysm Occlusion
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Assessment method [11]
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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.
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Timepoint [11]
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Assessed post-procedure and at a 180-day follow-up.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/10/2022
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
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4215 - Southport
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Salzburg
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Canada
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State/province [3]
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Toronto
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Country [4]
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France
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State/province [4]
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CA
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Country [5]
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France
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State/province [5]
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Montpellier
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Country [6]
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France
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State/province [6]
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Paris
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Country [7]
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Spain
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State/province [7]
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Barcelona
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Country [8]
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Spain
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State/province [8]
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Valladolid
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Country [9]
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Switzerland
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State/province [9]
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Corindus Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04236856
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Trial related presentations / publications
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.
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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Michel Piotin, MD, PhD
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Address
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Interventional Neuroradiologisit & Director, Foundation Rothschild
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04236856
Download to PDF