Robot-Assisted Neurovascular Intervention

NCT06752096 | Recruiting

• 1 other identifier: 2024-2751-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurovascular Disorder; Stroke; Meningioma

Keywords

Robot-assisted neurovascular Intervention; cerebral angiogram; Meningioma; Thrombectomy; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment through end of procedure.

Study Arms (1)

Robot Assisted Neurovascular Intervention

EXPERIMENTAL

Patients will undergo robot-assisted neurovascular interventions.

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.

Interventions

Cerebral angiogram using robotic device DEVICE

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

Robot Assisted Neurovascular Intervention

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.

Robot Assisted Neurovascular Intervention

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.

Robot Assisted Neurovascular Intervention

cerebral angiography, arterial embolization, thrombectomy PROCEDURE

This intervention will be conducted using robotic navigation.

Robot Assisted Neurovascular Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Severance Hospital, Yonsie University College of Medicine: collaborator
• Navigantis Inc.: lead

Study Sites (1)

Severence Hospital, Yonsei University College of Medicine

Seoul, Korea, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke; Meningioma; Ischemic Stroke

Interventions

Cerebral Angiography; Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Investigative Techniques; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ken Lock

CONTACT

612-910-3187; kenlock@navigantis.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: December 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

KR (1)