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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
Gold Coast University Hospital
Southport, Queensland, Australia
Uniklinikum Salzburg
Salzburg, Austria
Toronto Western Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Canada
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.
Time frame: 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.
Time frame: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.
Robotically Navigate Device to the Target Aneurysm
Defined as successful advancement of device to the target aneurysm robotically.
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.
Robotically Deploy Therapeutic Device Into the Target Aneurysm
Defined as successful deployment of therapeutic device into the target aneurysm robotically
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.
Overall Procedure Time
Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter
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.
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Hôpital Pitié-Salpêtrière
Paris, CA, France
CHU Montpellier - Hôpital Gui de Chauliac
Montpellier, France
Hôpital de la Fondation Rothschild
Paris, France
Vall d'Hebron University Hospital
Barcelona, Spain
University Clinical Hospital of Valladolid
Valladolid, Spain
Inselspital, Universitätsspital Bern
Bern, Switzerland
Fluoroscopy Time
Total fluoroscopy utilized during the procedure as recorded by the Imaging System
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.
Patient Radiation Exposure
DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure
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.
Contrast Fluid Volume
Total contrast used during the procedure
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.
Adverse Events
All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;
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
Number of Thromboembolic Events
Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure
Time frame: Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).
Devices Used Robotically
Recorded as successful or unsuccessful in conjunction with the CorPath GRX System
Time frame: Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day
Number of Participants With Aneurysm Occlusion
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.
Time frame: Assessed at 180 Day Follow-up
Number of Participants With Aneurysm Occlusion
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.
Time frame: Assessed During Procedure (Post Intervention)