CorPath® GRX Neuro Study

Headache Clinical Trial

Official title:

An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236856
• Other study ID #: 104-08660
• Status: Completed
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: October 12, 2022

Study information

• Verified date: May 2023
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 12, 2022
• Est. primary completion date: April 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Headache
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Intervention

Device:
• Robotic Endovascular Procedure
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.

Locations

Country	Name	City	State
Australia	Gold Coast University Hospital	Southport	Queensland
Austria	Uniklinikum Salzburg	Salzburg
Canada	St. Michael's Hospital	Toronto
Canada	Toronto Western Hospital	Toronto	Ontario
France	CHU Montpellier - Hôpital Gui de Chauliac	Montpellier
France	Hôpital de la Fondation Rothschild	Paris
France	Hôpital Pitié-Salpêtrière	Paris	CA
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	University Clinical Hospital of Valladolid	Valladolid
Switzerland	Inselspital, Universitätsspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  France,  Spain,  Switzerland, 

References & Publications (5)

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. — View Citation

Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured from the start of the procedure to the end of the procedure.
Primary	Incidence of Inta- 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.	Measured from the start of the procedure through 24 hours or discharge.
Secondary	Robotically Navigate Device to the Target Aneurysm	Defined as successful advancement of device to the target aneurysm robotically.	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	Robotically Navigate Device into the Target Aneurysm	Defined as successful navigation of device into the target aneurysm robotically	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	Robotically Deploy Therapeutic Device into the Target Aneurysm	Defined as successful deployment of therapeutic device into the target aneurysm robotically	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	Overall Procedure Time	Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter	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	Fluoroscopy Time	Total fluoroscopy utilized during the procedure as recorded by the Imaging System	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	Patient Radiation Exposure	DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure	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	Contrast Fluid Volume	Total contrast used during the procedure	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	Adverse Events	All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;	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	Thromboembolic Events	Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure	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	Devices Used Robotically	Recorded as successful or unsuccessful in conjunction with the CorPath GRX System	Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day
Secondary	Aneurysm Occlusion	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.	Assessed post-procedure and at a 180-day follow-up.