Back to resultsCorPath® GRX Neuro Study
Primary Purpose
Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Robotic Endovascular Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
Eligibility Criteria
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.
Sites / Locations
- Gold Coast University Hospital
- Uniklinikum Salzburg
- Toronto Western Hospital
- St. Michael's Hospital
- Hôpital Pitié-Salpêtrière
- CHU Montpellier - Hôpital Gui de Chauliac
- Hôpital de la Fondation Rothschild
- Vall d'Hebron University Hospital
- University Clinical Hospital of Valladolid
- Inselspital, Universitätsspital Bern
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Robotic Endovascular Procedure
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Robotically Navigate Device to the Target Aneurysm
Defined as successful advancement of device to the target aneurysm robotically.
Robotically Navigate Device into the Target Aneurysm
Defined as successful navigation of device into the target aneurysm robotically
Robotically Deploy Therapeutic Device into the Target Aneurysm
Defined as successful deployment of therapeutic device into the target aneurysm robotically
Overall Procedure Time
Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter
Fluoroscopy Time
Total fluoroscopy utilized during the procedure as recorded by the Imaging System
Patient Radiation Exposure
DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure
Contrast Fluid Volume
Total contrast used during 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;
Thromboembolic Events
Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure
Devices Used Robotically
Recorded as successful or unsuccessful in conjunction with the CorPath GRX System
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04236856
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
April 23, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corindus Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic Endovascular Procedure
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic Endovascular Procedure
Other Intervention Name(s)
CorPath GRX System
Intervention Description
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
Primary Outcome Measure Information:
Title
Procedural Technical Success.
Description
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.
Title
Incidence of Inta- and Peri-procedural Events.
Description
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.
Secondary Outcome Measure Information:
Title
Robotically Navigate Device to the Target Aneurysm
Description
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. Subjects will also undergo clinical follow-up through 180 days.
Title
Robotically Navigate Device into the Target Aneurysm
Description
Defined as successful navigation of 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. Subjects will also undergo clinical follow-up through 180 days.
Title
Robotically Deploy Therapeutic Device into the Target Aneurysm
Description
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. Subjects will also undergo clinical follow-up through 180 days.
Title
Overall Procedure Time
Description
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. Subjects will also undergo clinical follow-up through 180 days.
Title
Fluoroscopy Time
Description
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. Subjects will also undergo clinical follow-up through 180 days.
Title
Patient Radiation Exposure
Description
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. Subjects will also undergo clinical follow-up through 180 days.
Title
Contrast Fluid Volume
Description
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. Subjects will also undergo clinical follow-up through 180 days.
Title
Adverse Events
Description
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
Title
Thromboembolic Events
Description
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. 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
Title
Devices Used Robotically
Description
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
Title
Aneurysm Occlusion
Description
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.
Time Frame
Assessed post-procedure and at a 180-day follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Piotin, MD, PhD
Organizational Affiliation
Interventional Neuroradiologisit & Director, Foundation Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Uniklinikum Salzburg
City
Salzburg
Country
Austria
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
Country
Canada
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
State/Province
CA
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Montpellier - Hôpital Gui de Chauliac
City
Montpellier
Country
France
Facility Name
Hôpital de la Fondation Rothschild
City
Paris
ZIP/Postal Code
75940
Country
France
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
University Clinical Hospital of Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Inselspital, Universitätsspital Bern
City
Bern
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD.
Citations:
PubMed Identifier
28723321
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.
Results Reference
background
PubMed Identifier
26330064
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.
Results Reference
background
PubMed Identifier
22556195
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.
Results Reference
background
PubMed Identifier
23406828
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.
Results Reference
background
PubMed Identifier
18523626
Citation
Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
Results Reference
background
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CorPath® GRX Neuro Study
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