Robot-Assisted Neurovascular Intervention

NCT ID: NCT06752096

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-27
• Study Completion Date: 2026-12-02

Brief Summary

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.

Conditions

Stroke; Meningioma; Neurovascular Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Robot Assisted Neurovascular Intervention

Patients will undergo robot-assisted neurovascular interventions.

Group Type: EXPERIMENTAL

cerebral angiography, arterial embolization, thrombectomy

Intervention Type: PROCEDURE

This intervention will be conducted using robotic navigation.

Cerebral angiogram using robotic device

Intervention Type: DEVICE

Diagnostic cerebral angiogram will be performed using a robot to navigate guidewires and catheters to target vessels.

Meningioma embolization using robotic device.

Intervention Type: 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.

Intervention Type: DEVICE

Mechanical thrombectomy procedure will use a robot to navigate catheters, guidewires, and thrombectomy devices to the target vessel.

Interventions

cerebral angiography, arterial embolization, thrombectomy

This intervention will be conducted using robotic navigation.

Intervention Type: PROCEDURE

Cerebral angiogram using robotic device

Diagnostic cerebral angiogram will be performed using a robot to navigate guidewires and catheters to target vessels.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital, Yonsie University College of Medicine

UNKNOWN

Sponsor Role: collaborator

Navigantis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severence Hospital, Yonsei University College of Medicine

Seoul, Korea, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ken Lock

Role: CONTACT

kenlock@navigantis.co

612-910-3187

Facility Contacts

Haena Kim

Role: primary

khn715@yuhs.ac

82-10-5008-1433

Other Identifiers

2024-2751-002

Identifier Type: -

Identifier Source: org_study_id