Intracranial AneurysmNCT04236856
CorPath® GRX Neuro Study
A study testing Robotic Endovascular Procedure in people with Intracranial Aneurysm and Subarachnoid Hemorrhage, run by Siemens Healthineers Endovascular Robotics, Inc. at 10 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache
- What is being tested?
- Robotic Endovascular Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 21 Aug 2020to 12 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
France3 sites
CHU Montpellier - Hôpital Gui de Chauliac
Montpellier
Hôpital Pitié-Salpêtrière
Paris, CA, 75013
Hôpital de la Fondation Rothschild
Paris, 75940
Canada2 sites
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
St. Michael's Hospital
Toronto
Spain2 sites
Vall d'Hebron University Hospital
Barcelona, 08035
University Clinical Hospital of Valladolid
Valladolid, 47003
About this study
Official title: An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
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.
Read the 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.
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache
- Being tested
- Robotic Endovascular Procedure
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Endovascular ProcedureDevice
Also called CorPath GRX System
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Endovascular Procedure | Other | 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. Receives: Device: Robotic Endovascular Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.
Secondary outcomes (11)
Robotically Navigate Device to the Target Aneurysm
Defined as successful advancement of device to the target aneurysm robotically.
Measured: 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
Measured: 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
Measured: 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.
Fluoroscopy Time
Total fluoroscopy utilized during the procedure as recorded by the Imaging System
Measured: 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
Measured: 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
Measured: 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;
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Assessed During Procedure (Post Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start21 Aug 2020
- Primary completion23 Apr 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Piotin, MD, PhD, Principal investigator, Interventional Neuroradiologisit & Director, Foundation Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236856
- Sponsor's protocol ID
- 104-08660
- Status last verified
- Feb 2025
- First submitted
- 2 Jan 2020
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Publications
Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.
PubMed 28723321Lantigua 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.
PubMed 26330064Connolly 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.
PubMed 22556195Steiner 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.
PubMed 23406828Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
PubMed 18523626Mendes Pereira V, Rice H, De Villiers L, Sourour N, Clarencon F, Spears J, Tomasello A, Hernandez D, Cancelliere NM, Liu XYE, Nicholson P, Costalat V, Gascou G, Mordasini P, Gralla J, Martinez-Galdamez M, Galvan Fernandez J, Killer-Oberpfalzer M, Liebeskind DS, Turner RD, Blanc R, Piotin M. Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms. J Neurointerv Surg. 2024 Mar 14;16(4):405-411. doi: 10.1136/jnis-2023-020161.
PubMed 37793795
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
- ClinicalTrials.gov ID
- NCT04236856
- Acronym / sponsor ID
- 104-08660
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robotic Endovascular Procedure | Other | Device: Robotic Endovascular ProcedureSubjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Endovascular ProcedureAlso: CorPath GRX SystemAfter providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System. | Device | Robotic Endovascular Procedure |
Primary outcome
Number of Participants With Procedural Technical Success.
Time frame: 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.
Time frame: 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.
11 secondary outcomes
Robotically Navigate Device to the Target Aneurysm
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
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
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.
Fluoroscopy Time
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
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
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
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
Time frame: Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).
Devices Used Robotically
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
Time frame: Assessed at 180 Day Follow-up
Number of Participants With Aneurysm Occlusion
Time frame: Assessed During Procedure (Post Intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28723321Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.
- Background: PubMed 26330064Lantigua 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.
- Background: PubMed 22556195Connolly 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.
- Background: PubMed 23406828Steiner 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.
- Background: PubMed 18523626Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
- Derived from this study: PubMed 37793795Mendes Pereira V, Rice H, De Villiers L, Sourour N, Clarencon F, Spears J, Tomasello A, Hernandez D, Cancelliere NM, Liu XYE, Nicholson P, Costalat V, Gascou G, Mordasini P, Gralla J, Martinez-Galdamez M, Galvan Fernandez J, Killer-Oberpfalzer M, Liebeskind DS, Turner RD, Blanc R, Piotin M. Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms. J Neurointerv Surg. 2024 Mar 14;16(4):405-411. doi: 10.1136/jnis-2023-020161.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Piotin, MD, PhD principal investigator
Interventional Neuroradiologisit & Director, Foundation Rothschild
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Endovascular Procedure in people with Intracranial Aneurysm and Subarachnoid Hemorrhage, run by Siemens Healthineers Endovascular Robotics, Inc. at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Canada, Spain, Australia, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Procedural Technical Success. (time frame: Measured from the start of the procedure to the end of the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236856, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.