An interventional study of Robotic Endovascular Procedure in Intracranial Aneurysm, Subarachnoid Hemorrhage and Headache, sponsored by Corindus Inc.. Completed at 10 sites in 6 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Corindus Inc. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Device: Robotic Endovascular Procedure
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
Also known as: CorPath GRX System
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.
Time frame: 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.
Time frame: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.
Robotically Navigate Device to the Target Aneurysm
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.
Robotically Deploy Therapeutic Device Into the Target Aneurysm
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.
Overall Procedure Time
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.
Fluoroscopy Time
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.
Patient Radiation Exposure
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.
Contrast Fluid Volume
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.
Adverse Events
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
Number of Thromboembolic Events
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 (180-days following the robotic-assisted procedure).
Devices Used Robotically
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
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.
Time frame: 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.
Time frame: Assessed During Procedure (Post Intervention)
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.
| Milestone | Robotic Endovascular Procedure |
|---|---|
| Started | 120 |
| Completed | 117 |
| Not completed | 3 |
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.
| Participants | Robotic Endovascular Procedure |
|---|---|
| Number of Participants With Procedural Technical Success. | 110 |
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.
| Events | Robotic Endovascular Procedure |
|---|---|
| Number of Intra- and Peri-procedural Events. | 4 |
Defined as successful advancement of device to the target aneurysm robotically.
Results for this outcome have not been posted.
Defined as successful deployment of therapeutic device into the target aneurysm robotically
Results for this outcome have not been posted.
Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter
| minutes | Robotic Endovascular Procedure |
|---|---|
| Overall Procedure Time | 117.3 ± 47.3 |
Total fluoroscopy utilized during the procedure as recorded by the Imaging System
| minutes | Robotic Endovascular Procedure |
|---|---|
| Fluoroscopy Time | 51.9 ± 27.4 |
DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure
| mGy*cm2 | Robotic Endovascular Procedure |
|---|---|
| Patient Radiation Exposure | 6886135.5 ± 25767850.8 |
Total contrast used during the procedure
| cc | Robotic Endovascular Procedure |
|---|---|
| Contrast Fluid Volume | 185.4 ± 82.3 |
All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;
Results for this outcome have not been posted.
Rate of thromboembolic events occurring up to 180-days following the robotic-assisted procedure
| Events | Robotic Endovascular Procedure |
|---|---|
| Number of Thromboembolic Events | 17 |
Recorded as successful or unsuccessful in conjunction with the CorPath GRX System
Results for this outcome have not been posted.
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.
| Participants | Robotic Endovascular Procedure |
|---|---|
| Raymond Roy Classification Scale 1 | 96 |
| Raymond Roy Classification Scale 2 | 2 |
| Raymond Roy Classification Scale 3A | 2 |
| Raymond Roy Classification Scale 3B | 2 |
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.
| Participants | Robotic Endovascular Procedure |
|---|---|
| Raymond Roy Classification Scale 1 | 71 |
| Raymond Roy Classification Scale 2 | 5 |
| Raymond Roy Classification Scale 3A | 28 |
| Raymond Roy Classification Scale 3B | 6 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robotic Endovascular Procedure | 1/117 (0.9%) | 40/117 (34.2%) | 21/117 (17.9%) |
| Event | Robotic Endovascular Procedure |
|---|---|
| StrokeNervous system disorders | 17/117 |
| Vascular Access Site ComplicationInjury, poisoning and procedural complications | 4/117 |
| Transient Ischemic AttackNervous system disorders | 3/117 |
| Intraprocedural Aneurysm RuptureNervous system disorders | 2/117 |
| AphasiaNervous system disorders | 1/117 |
| Confusion EpisodeNervous system disorders | 1/117 |
| Digestive BleedingGastrointestinal disorders | 1/117 |
| EmbolismBlood and lymphatic system disorders | 1/117 |
| Extremity IschemiaVascular disorders | 1/117 |
| Fibula FractureMusculoskeletal and connective tissue disorders | 1/117 |
| Event | Robotic Endovascular Procedure |
|---|---|
| HeadacheNervous system disorders | 8/117 |
| Vascular Site Access ComplicationInjury, poisoning and procedural complications | 2/117 |
| Electrolyte DisorderEndocrine disorders | 2/117 |
| TinnitusNervous system disorders | 2/117 |
| Confusion EpisodeNervous system disorders | 1/117 |
| Sensory DeficitNervous system disorders | 1/117 |
| DiabetesEndocrine disorders | 1/117 |
| GalactorrheaEndocrine disorders | 1/117 |
| HemianopiaEye disorders | 1/117 |
| Urine InfectionInfections and infestations | 1/117 |
| Age, Continuous(YEARS) | Robotic Endovascular Procedure |
|---|---|
| Mean | 56.6 ± 12.7 |
| Sex: Female, Male(Participants) | Robotic Endovascular Procedure |
|---|---|
| Female | 87 |
| Male | 30 |
| Race and Ethnicity Not Collected(Participants) | Robotic Endovascular Procedure |
|---|
| Region of Enrollment(participants) | Robotic Endovascular Procedure |
|---|---|
| Canada | 30 |
| Austria | 2 |
| France | 49 |
| Australia | 24 |
| Switzerland | 3 |
| Spain | 9 |
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Plan to share: No — No plan to share IPD.
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Corindus Inc.