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Recruiting

NCT Number: NCT06752096

Robot-Assisted Neurovascular Intervention

Patients scheduled for neurovascular interventions may be eligible to have their procedure done robotically.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severence Hospital, Yonsei University College of Medicine

Seoul, Korea, South Korea

Location status: Recruiting

Location contact

Haena Kim

CONTACT

[email protected]

82-10-5008-1433

Jun Ho Kwon Prof.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):

  • 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.
  • 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.

Exclusion criteria

2 (Cerebral Ischemic Stroke Patient):

  • 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.

Treatment and study plan

cerebral angiography, arterial embolization, thrombectomy

Procedure

This intervention will be conducted using robotic navigation.

Cerebral angiogram using robotic device

Device

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ken Lock

CONTACT

[email protected]

612-910-3187

Sponsors and collaborators

Lead sponsor

Navigantis Inc.

Industry

Collaborators

  • Severance Hospital, Yonsie University College of Medicine

Registry information

Official study title

Robot-assisted Neurovascular Intervention for Patients Indicated for Angiography, Cerebral Artery Embolization, and Thrombectomy: Exploratory Study to Compare to Existing Interventional Procedures

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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