StrokeNCT06752096
Robot-Assisted Neurovascular Intervention
A study testing cerebral angiography, arterial embolization, thrombectomy, Cerebral angiogram using robotic device and Meningioma embolization using robotic device. in people with Stroke and Meningioma, run by Navigantis Inc. at 1 site in South Korea.
Trial summary
Patients scheduled for neurovascular interventions may be eligible to have their procedure done robotically. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Meningioma, Neurovascular Disorder
- What is being tested?
- cerebral angiography, arterial embolization, thrombectomy, Cerebral angiogram using robotic device and Meningioma embolization using robotic device.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2024to 2 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, are selected according to the same criteria as standard cerebral angiography and interventional procedures.
Who cannot join
- Patients who have undergone surgery within 4 weeks prior to study participation or have not fully recovered from surgery.
- Patients who are pregnant or breastfeeding.
- Patients with existing or anticipated vasospasm, bleeding, or severe atheromatous disease.
- Patients allergic to contrast agents used in angiography.
- Patients with renal failure.
- Patients with a history of cardiac events, such as myocardial infarction or superior vena cava (SVC) syndrome, within 3 months prior to study participation, or with existing heart disease.
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- Patients unable to cooperate due to difficulty in expressing intent to the extent that the procedure cannot proceed.
- Patients with severe or life-threatening comorbidities that could significantly affect symptom improvement or render the procedure unbeneficial.
- Patients with non-life-threatening comorbidities that prevent proper follow-up for treatment.
- Patients with an ASPECTS score of 0-2 on a pre-treatment non-contrast CT.
- Inability to perform femoral puncture within 60 minutes of completing CT angiography (if CT perfusion is performed, it must be done after CT angiography).
- Absence of a femoral pulse.
- Cases where vascular access is highly challenging, with an anticipated time exceeding 90 minutes from CT angiography to reperfusion.
- Patients suspected to have cerebral artery dissection or atherosclerosis as the cause of stroke.
- Patients where the intracranial occlusion is determined to be chronic based on clinical history, prior imaging, or clinical judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severence Hospital, Yonsei University College of Medicine
Seoul, Korea
Haena Kim, 82-10-5008-1433, khn715@yuhs.ac
Jun Ho Kwon Prof.
About this study
Official title: Robot-assisted Neurovascular Intervention for Patients Indicated for Angiography, Cerebral Artery Embolization, and Thrombectomy: Exploratory Study to Compare to Existing Interventional Procedures
Patients scheduled for neurovascular interventions may be eligible to have their procedure done robotically.
Read the detailed description
Patients scheduled for manual neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, may be considered to participate in this study.
- Conditions
- Stroke, Meningioma, Neurovascular Disorder
- Being tested
- cerebral angiography, arterial embolization, thrombectomy, Cerebral angiogram using robotic device, Meningioma embolization using robotic device., Mechanical thrombectomy for stroke using a robotic device.
- Keywords
- Robot-assisted neurovascular Intervention, cerebral angiogram, Meningioma, Thrombectomy, Ischemic Stroke
- Medical subject headings
- Stroke, Meningioma, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral angiography, arterial embolization, thrombectomyProcedure or surgery
This intervention will be conducted using robotic navigation.
Cerebral angiogram using robotic deviceDevice
Diagnostic cerebral angiogram will be performed using a robot to navigate guidewires and catheters to target vessels.
Meningioma embolization using robotic device.Device
Meningioma tumors will be embolized using a robot to navigate catheters and wires to the target vessels to the tumor.
Mechanical thrombectomy for stroke using a robotic device.Device
Mechanical thrombectomy procedure will use a robot to navigate catheters, guidewires, and thrombectomy devices to the target vessel.
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Neurovascular Intervention | Experimental | Patients will undergo robot-assisted neurovascular interventions. Receives: Procedure: cerebral angiography, arterial embolization, thrombectomy; Device: Cerebral angiogram using robotic device; Device: Meningioma embolization using robotic device.; Device: Mechanical thrombectomy for stroke using a robotic device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of target vessel access
Measurement Parameters: The primary outcome assesses whether the Vasco Robotic system navigates catheter or other procedural devices successfully to the target vessel.
Measured: From enrollment through end of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start27 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navigantis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Yonsie University College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752096
- Sponsor's protocol ID
- 2024-2751-002
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Neurovascular Intervention for Patients Indicated for Angiography, Cerebral Artery Embolization, and Thrombectomy: Exploratory Study to Compare to Existing Interventional Procedures
- ClinicalTrials.gov ID
- NCT06752096
- Acronym / sponsor ID
- 2024-2751-002
- Conditions
- Stroke, Meningioma, Neurovascular Disorder
- Keywords
- Robot-assisted neurovascular Intervention, cerebral angiogram, Meningioma, Thrombectomy, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Navigantis Inc.Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Yonsie University College of Medicine
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients scheduled for neurovascular interventions may be eligible to have their procedure done robotically.
Detailed description
Patients scheduled for manual neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, may be considered to participate in this study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Neurovascular Intervention | Experimental | Procedure: cerebral angiography, arterial embolization, thrombectomy, Device: Cerebral angiogram using robotic device, Device: Meningioma embolization using robotic device., Device: Mechanical thrombectomy for stroke using a robotic device.Patients will undergo robot-assisted neurovascular interventions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, are selected according to the same criteria as standard cerebral angiography and interventional procedures.
Key exclusion criteria (15 listed)
- Patients who have undergone surgery within 4 weeks prior to study participation or have not fully recovered from surgery.
- Patients who are pregnant or breastfeeding.
- Patients with existing or anticipated vasospasm, bleeding, or severe atheromatous disease.
- Patients allergic to contrast agents used in angiography.
- Patients with renal failure.
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 |
|---|---|---|
| cerebral angiography, arterial embolization, thrombectomyThis intervention will be conducted using robotic navigation. | Procedure or surgery | Robot Assisted Neurovascular Intervention |
| Cerebral angiogram using robotic deviceDiagnostic cerebral angiogram will be performed using a robot to navigate guidewires and catheters to target vessels. | Device | Robot Assisted Neurovascular Intervention |
| Meningioma embolization using robotic device.Meningioma tumors will be embolized using a robot to navigate catheters and wires to the target vessels to the tumor. | Device | Robot Assisted Neurovascular Intervention |
| Mechanical thrombectomy for stroke using a robotic device.Mechanical thrombectomy procedure will use a robot to navigate catheters, guidewires, and thrombectomy devices to the target vessel. | Device | Robot Assisted Neurovascular Intervention |
Primary outcome
Success rate of target vessel access
Time frame: From enrollment through end of procedure.
Measurement Parameters: The primary outcome assesses whether the Vasco Robotic system navigates catheter or other procedural devices successfully to the target vessel.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebral angiography, arterial embolization, thrombectomy, Cerebral angiogram using robotic device and Meningioma embolization using robotic device. in people with Stroke and Meningioma, run by Navigantis Inc. at 1 site in South Korea.
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 1 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ken Lock (612-910-3187, kenlock@navigantis.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of target vessel access (time frame: From enrollment through end of procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.