Clinical trial NCT04236856: CorPath® GRX Neuro Study
Official title: An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Subarachnoid Hemorrhage
Headache
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants With Procedural Technical Success.
timeFrame: Measured from the start of the procedure to the end of the procedure.
measure: Number of Intra- and Peri-procedural Events.
timeFrame: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.
Secondary outcomes:
measure: Robotically Navigate Device to the Target Aneurysm
timeFrame: 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.
measure: Robotically Deploy Therapeutic Device Into the Target Aneurysm
timeFrame: 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.
measure: Overall Procedure Time
timeFrame: 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.
measure: Fluoroscopy Time
timeFrame: 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.
measure: Patient Radiation Exposure
timeFrame: 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.
measure: Contrast Fluid Volume
timeFrame: 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.
measure: Adverse Events
timeFrame: 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
measure: Number of Thromboembolic Events
timeFrame: Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).
measure: Devices Used Robotically
timeFrame: Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day
measure: Number of Participants With Aneurysm Occlusion
timeFrame: Assessed at 180 Day Follow-up
measure: Number of Participants With Aneurysm Occlusion
timeFrame: Assessed During Procedure (Post Intervention)
Other outcomes:
Locations:
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
state: CA
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital Gui de Chauliac
city: Paris
country: France
facility: Hôpital de la Fondation Rothschild
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Valladolid
country: Spain
facility: University Clinical Hospital of Valladolid
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
Study officials:
affiliation: Interventional Neuroradiologisit & Director, Foundation Rothschild
name: Michel Piotin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.