Trial Outcomes & Findings for CorPath® GRX Neuro Study (NCT NCT04236856)
NCT ID: NCT04236856
Last Updated: 2025-03-06
Results Overview
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.
COMPLETED
NA
120 participants
Measured from the start of the procedure to the end of the procedure.
2025-03-06
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
117
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Robotic Endovascular Procedure
n=117 Participants
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.
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|---|---|
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Age, Continuous
|
56.6 YEARS
STANDARD_DEVIATION 12.7 • n=117 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=117 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=117 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=117 Participants
|
|
Region of Enrollment
France
|
49 participants
n=117 Participants
|
|
Region of Enrollment
Australia
|
24 participants
n=117 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=117 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=117 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=117 Participants
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.
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|---|---|
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Number of Participants With Procedural Technical Success.
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110 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=117 Participants
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.
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|---|---|
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Number of Intra- and Peri-procedural Events.
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4 Events
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SECONDARY outcome
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.Defined as successful advancement of device to the target aneurysm robotically.
Outcome measures
Outcome data not reported
SECONDARY outcome
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.Defined as successful deployment of therapeutic device into the target aneurysm robotically
Outcome measures
Outcome data not reported
SECONDARY outcome
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.Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=117 Participants
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.
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|---|---|
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Overall Procedure Time
|
117.3 minutes
Standard Deviation 47.3
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SECONDARY outcome
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.Total fluoroscopy utilized during the procedure as recorded by the Imaging System
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=117 Participants
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.
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|---|---|
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Fluoroscopy Time
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51.9 minutes
Standard Deviation 27.4
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SECONDARY outcome
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.DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=104 Participants
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.
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|---|---|
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Patient Radiation Exposure
|
6886135.5 mGy*cm2
Standard Deviation 25767850.8
|
SECONDARY outcome
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.Total contrast used during the procedure
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=116 Participants
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.
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|---|---|
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Contrast Fluid Volume
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185.4 cc
Standard Deviation 82.3
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SECONDARY outcome
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 thAll adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=117 Participants
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.
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|---|---|
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Number of Thromboembolic Events
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17 Events
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SECONDARY outcome
Timeframe: Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 dayRecorded as successful or unsuccessful in conjunction with the CorPath GRX System
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 180 Day Follow-upAngiographic 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.
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=102 Participants
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.
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|---|---|
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Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 1
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96 Participants
|
|
Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 2
|
2 Participants
|
|
Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 3A
|
2 Participants
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Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 3B
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed During Procedure (Post Intervention)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.
Outcome measures
| Measure |
Robotic Endovascular Procedure
n=110 Participants
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.
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|---|---|
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Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 1
|
71 Participants
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|
Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 2
|
5 Participants
|
|
Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 3A
|
28 Participants
|
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Number of Participants With Aneurysm Occlusion
Raymond Roy Classification Scale 3B
|
6 Participants
|
Adverse Events
Robotic Endovascular Procedure
Serious adverse events
| Measure |
Robotic Endovascular Procedure
n=117 participants at risk
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.
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|---|---|
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Nervous system disorders
Stroke
|
14.5%
17/117 • 6 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Complication
|
3.4%
4/117 • 6 months
|
|
Nervous system disorders
Transient Ischemic Attack
|
2.6%
3/117 • 6 months
|
|
Nervous system disorders
Aphasia
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0.85%
1/117 • 6 months
|
|
Nervous system disorders
Confusion Episode
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0.85%
1/117 • 6 months
|
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Gastrointestinal disorders
Digestive Bleeding
|
0.85%
1/117 • 6 months
|
|
Blood and lymphatic system disorders
Embolism
|
0.85%
1/117 • 6 months
|
|
Vascular disorders
Extremity Ischemia
|
0.85%
1/117 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fibula Fracture
|
0.85%
1/117 • 6 months
|
|
Nervous system disorders
Flow Diverter Endovascular Procedure
|
0.85%
1/117 • 6 months
|
|
Nervous system disorders
Headache
|
0.85%
1/117 • 6 months
|
|
Nervous system disorders
Hydrocephalus
|
0.85%
1/117 • 6 months
|
|
Nervous system disorders
Intraprocedural Aneurysm Rupture
|
1.7%
2/117 • 6 months
|
|
Injury, poisoning and procedural complications
Perforated Sigmoid Diverticulitis
|
0.85%
1/117 • 6 months
|
|
Blood and lymphatic system disorders
Relapsed Leukemia
|
0.85%
1/117 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.85%
1/117 • 6 months
|
|
Nervous system disorders
Revascularization
|
0.85%
1/117 • 6 months
|
|
Injury, poisoning and procedural complications
Right radial pseudoaneurysm
|
0.85%
1/117 • 6 months
|
Other adverse events
| Measure |
Robotic Endovascular Procedure
n=117 participants at risk
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.
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|---|---|
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Nervous system disorders
Headache
|
6.8%
8/117 • 6 months
|
|
Injury, poisoning and procedural complications
Vascular Site Access Complication
|
1.7%
2/117 • 6 months
|
|
Endocrine disorders
Electrolyte Disorder
|
1.7%
2/117 • 6 months
|
|
Nervous system disorders
Confusion Episode
|
0.85%
1/117 • 6 months
|
|
Nervous system disorders
Sensory Deficit
|
0.85%
1/117 • 6 months
|
|
Nervous system disorders
Tinnitus
|
1.7%
2/117 • 6 months
|
|
Endocrine disorders
Diabetes
|
0.85%
1/117 • 6 months
|
|
Endocrine disorders
Galactorrhea
|
0.85%
1/117 • 6 months
|
|
Eye disorders
Hemianopia
|
0.85%
1/117 • 6 months
|
|
Infections and infestations
Urine Infection
|
0.85%
1/117 • 6 months
|
|
Vascular disorders
Vasospasm
|
0.85%
1/117 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place