CorPath® GRX Neuro Study

Not Applicable

Completed

Conditions: Headache
Subarachnoid Hemorrhage
Intracranial Aneurysm

Interventions: Device: Robotic Endovascular Procedure

Registration Number: NCT04236856

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Endovascular Procedure	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Technical Success.	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.
Number of Intra- and Peri-procedural Events.	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 Outcome Measures

Name	Time	Method
Robotically Navigate Device to the Target Aneurysm	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.
Robotically Deploy Therapeutic Device Into the Target Aneurysm	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
Overall Procedure Time	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
Fluoroscopy Time	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
Patient Radiation Exposure	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
Contrast Fluid Volume	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
Adverse Events	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;
Number of Thromboembolic Events	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
Devices Used Robotically	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
Number of Participants With Aneurysm Occlusion	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.

Trial Locations

Locations (10): Vall d'Hebron University Hospital
🇪🇸
Barcelona, Spain
Toronto Western Hospital
🇨🇦
Toronto, Ontario, Canada
Hôpital Pitié-Salpêtrière
🇫🇷
Paris, CA, France
Hôpital de la Fondation Rothschild
🇫🇷
Paris, France
CHU Montpellier - Hôpital Gui de Chauliac
🇫🇷
Montpellier, France
St. Michael's Hospital
🇨🇦
Toronto, Canada
University Clinical Hospital of Valladolid
🇪🇸
Valladolid, Spain
Gold Coast University Hospital
🇦🇺
Southport, Queensland, Australia
Inselspital, Universitätsspital Bern
🇨🇭
Bern, Switzerland
Uniklinikum Salzburg
🇦🇹
Salzburg, Austria