Robot-Assisted Neurovascular Intervention

January 14, 2026 updated by: Navigantis Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Korea
      • Seoul, Korea, South Korea
        • Recruiting
        • Severence Hospital, Yonsei University College of Medicine
        • Contact:
        • Principal Investigator:
          • Jun Ho Kwon Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion Criteria 1 (General):

  1. Patients who have undergone surgery within 4 weeks prior to study participation or have not fully recovered from surgery.
  2. Patients who are pregnant or breastfeeding.
  3. Patients with existing or anticipated vasospasm, bleeding, or severe atheromatous disease.
  4. Patients allergic to contrast agents used in angiography.
  5. Patients with renal failure.
  6. 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.
  7. Patients unable to cooperate due to difficulty in expressing intent to the extent that the procedure cannot proceed.
  8. Patients with severe or life-threatening comorbidities that could significantly affect symptom improvement or render the procedure unbeneficial.
  9. Patients with non-life-threatening comorbidities that prevent proper follow-up for treatment.

Exclusion Criteria 2 (Cerebral Ischemic Stroke Patient):

  1. Patients with an ASPECTS score of 0-2 on a pre-treatment non-contrast CT.
  2. Inability to perform femoral puncture within 60 minutes of completing CT angiography (if CT perfusion is performed, it must be done after CT angiography).
  3. Absence of a femoral pulse.
  4. Cases where vascular access is highly challenging, with an anticipated time exceeding 90 minutes from CT angiography to reperfusion.
  5. Patients suspected to have cerebral artery dissection or atherosclerosis as the cause of stroke.
  6. Patients where the intracranial occlusion is determined to be chronic based on clinical history, prior imaging, or clinical judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot Assisted Neurovascular Intervention
Patients will undergo robot-assisted neurovascular interventions.
Procedure: cerebral angiography, arterial embolization, thrombectomy
This intervention will be conducted using robotic navigation.
Device: Cerebral angiogram using robotic device
Diagnostic cerebral angiogram will be performed using a robot to navigate guidewires and catheters to target vessels.
Device: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment through end of procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navigantis Inc.

Collaborators

Severance Hospital, Yonsie University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 2, 2026

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

December 30, 2024

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2751-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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