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. (part of Siemens Healthineers) · Not applicable, Interventional, and Treatment
Among 66 studies in Intracranial Aneurysm with a site in France — 20 open to participants now, 27 under way, 1 of them phase 3. Intracranial Aneurysm · France.
Among the 66 studies in Intracranial Aneurysm with a site in France, this one is the 14th largest by enrollment of the 23 interventional ones that give a count, is one of 7 that started in 2020, is one of 18 with no phase, and was the 41st registered.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
Browse Intracranial Aneurysm studies →20 of the 66 studies in Intracranial Aneurysm with a site in France are open now. Recruiting first, the newest first:
Resolve Stroke · Sites in France
Ages 18+
CHU de Reims · Sites in France
Ages 18+
Sim&Cure · Sites in France
Ages 18+
Phenox GmbH · Sites in France, Germany, Italy and 2 more countries
Artiria Medical · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
66 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 7 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 120 is above the median of 100 across 207 interventional studies indexed under Intracranial Aneurysm.
Median enrollment 171 across the 23 interventional studies, 206 across the 43 observational. Of the 36 that completed or were terminated, 5 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
37 of 66 have an industry lead sponsor. The 10 most frequent:
This study is registered under Corindus Inc., one of the names counted as Siemens Healthineers. Under that name alone:
Corindus Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Siemens Healthineers has 1 study filed under Intracranial Aneurysm — fewer than ten, so there is no comparison to draw.
5 of the studies in Intracranial Aneurysm with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04192955Phase 3University of CalgaryEvaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms | 2027-03 |
| NCT07864389Resolve StrokeMultimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms | 2026-11 |
| NCT06940934Acandis GmbHPost-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE | 2026-12 |
| NCT06972953Artiria MedicalNEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I) | 2026-12 |
| NCT06689410Nantes University HospitalMultimodal Biocollection Linked to the French Register of Intracranial Aneurysms | 2027-03-25 |
Add all 5 to your calendar (.ics) → With an account.
Among the 66 studies in Intracranial Aneurysm with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No plan to share IPD.
Ran from Aug 2020 to primary completion in Apr 2022, 20 months.
Results were first posted in Mar 2025, 2 years 10 months after primary completion.
Of 48 industry-sponsored interventional studies with no phase under Intracranial Aneurysm, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 49. This study's 20 months is below that.
Counting every sponsor, half of 104 studies reached it within 39 months; a quarter within 22 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.