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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
Secondary ID [1] 0 0
104-08660
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysm 0 0
Subarachnoid Hemorrhage 0 0
Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedural Technical Success.
Timepoint [1] 0 0
Measured from the start of the procedure to the end of the procedure.
Primary outcome [2] 0 0
Incidence of Inta- and Peri-procedural Events.
Timepoint [2] 0 0
Measured from the start of the procedure through 24 hours or discharge.
Secondary outcome [1] 0 0
Robotically Navigate Device to the Target Aneurysm
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Robotically Navigate Device into the Target Aneurysm
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Robotically Deploy Therapeutic Device into the Target Aneurysm
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Overall Procedure Time
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Fluoroscopy Time
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Patient Radiation Exposure
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Contrast Fluid Volume
Timepoint [7] 0 0
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.
Secondary outcome [8] 0 0
Adverse Events
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Thromboembolic Events
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Devices Used Robotically
Timepoint [10] 0 0
Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day
Secondary outcome [11] 0 0
Aneurysm Occlusion
Timepoint [11] 0 0
Assessed post-procedure and at a 180-day follow-up.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2022
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Toronto
Country [4] 0 0
France
State/province [4] 0 0
CA
Country [5] 0 0
France
State/province [5] 0 0
Montpellier
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Valladolid
Country [9] 0 0
Switzerland
State/province [9] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Corindus Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04236856
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.
Public notes

Contacts
Principal investigator
Name 0 0
Michel Piotin, MD, PhD
Address 0 0
Interventional Neuroradiologisit & Director, Foundation Rothschild
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04236856