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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Endovascular Procedure | Device | After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 from the start of the procedure through 24 hours or discharge, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Robotically Deploy Therapeutic Device Into the Target Aneurysm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Piotin, MD, PhD | Interventional Neuroradiologisit & Director, Foundation Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia | ||
| Uniklinikum Salzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28723321 | Background | Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available. | |
| 26330064 | Background | 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. |
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No plan to share IPD.
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The clinical investigation started with enrollment of first subject on 21 August 2020 and subject recruitment was completed on 21 April 2022. With 10 investigational sites, up to 120 subjects were enrolled in order to achieve at least 108 subjects in the study; each site was initially approved to recruit a maximum of 20 subjects. The total study duration was 24 months: the recruitment phase was 18 months and follow-up continues to 180 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Robotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Robotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Measured from the start of the procedure to the end of the procedure. |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Robotic Endovascular Procedure: After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Corindus | 6173012445 | hamid.rai@siemens-healthineers.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 21, 2021 | Sep 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2022 | Sep 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D013345 | Subarachnoid Hemorrhage |
| D006261 | Headache |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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|
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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| Number of 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 (180-days following the robotic-assisted procedure). |
| 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 |
| 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. | 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. | Assessed During Procedure (Post Intervention) |
| Salzburg |
| Austria |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| St. Michael's Hospital | Toronto | Canada |
| Hôpital Pitié-Salpêtrière | Paris | CA | 75013 | France |
| CHU Montpellier - Hôpital Gui de Chauliac | Montpellier | France |
| Hôpital de la Fondation Rothschild | Paris | 75940 | France |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| University Clinical Hospital of Valladolid | Valladolid | 47003 | Spain |
| Inselspital, Universitätsspital Bern | Bern | Switzerland |
| 22556195 | Background | 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. |
| 23406828 | Background | 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. |
| 18523626 | Background | Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6. |
| 37793795 | Derived | Mendes 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. |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Number | Events | Measured from the start of the procedure through 24 hours or discharge, whichever occurs first. |
|
|
|
| Secondary | Robotically Navigate Device to the Target Aneurysm | Defined as successful advancement of device to the target aneurysm robotically. | Not Posted | 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. | Participants |
| Secondary | Robotically Deploy Therapeutic Device Into the Target Aneurysm | Defined as successful deployment of therapeutic device into the target aneurysm robotically | Not Posted | 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. | Participants |
| Secondary | Overall Procedure Time | Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter | Posted | Mean | Standard Deviation | minutes | 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. |
|
|
|
| Secondary | Fluoroscopy Time | Total fluoroscopy utilized during the procedure as recorded by the Imaging System | Posted | Mean | Standard Deviation | minutes | 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. |
|
|
|
| Secondary | Patient Radiation Exposure | DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure | Posted | Mean | Standard Deviation | mGy*cm2 | 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. |
|
|
|
| Secondary | Contrast Fluid Volume | Total contrast used during the procedure | Posted | Mean | Standard Deviation | cc | 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. |
|
|
|
| Secondary | Adverse Events | All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized; | Not Posted | 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 | Participants |
| Secondary | Number of Thromboembolic Events | Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure | Posted | Number | Events | Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure). |
|
|
|
| Secondary | Devices Used Robotically | Recorded as successful or unsuccessful in conjunction with the CorPath GRX System | Not Posted | Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day | Participants |
| Secondary | 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. | Posted | Count of Participants | Participants | Assessed at 180 Day Follow-up |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Assessed During Procedure (Post Intervention) |
|
|
|
| 1 |
| 117 |
| 40 |
| 117 |
| 21 |
| 117 |
| Vascular Access Site Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
|
| Aphasia | Nervous system disorders | Systematic Assessment |
|
| Confusion Episode | Nervous system disorders | Systematic Assessment |
|
| Digestive Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Embolism | Blood and lymphatic system disorders | Systematic Assessment |
|
| Extremity Ischemia | Vascular disorders | Systematic Assessment |
|
| Fibula Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flow Diverter Endovascular Procedure | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Intraprocedural Aneurysm Rupture | Nervous system disorders | Systematic Assessment |
|
| Perforated Sigmoid Diverticulitis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Relapsed Leukemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Revascularization | Nervous system disorders | Systematic Assessment |
|
| Right radial pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vascular Site Access Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Electrolyte Disorder | Endocrine disorders | Systematic Assessment |
|
| Confusion Episode | Nervous system disorders | Systematic Assessment |
|
| Sensory Deficit | Nervous system disorders | Systematic Assessment |
|
| Tinnitus | Nervous system disorders | Systematic Assessment |
|
| Diabetes | Endocrine disorders | Systematic Assessment |
|
| Galactorrhea | Endocrine disorders | Systematic Assessment |
|
| Hemianopia | Eye disorders | Systematic Assessment |
|
| Urine Infection | Infections and infestations | Systematic Assessment |
|
| Vasospasm | Vascular disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Raymond Roy Classification Scale 3B |
|
| Raymond Roy Classification Scale 3B |
|