Robot-Assisted Neurovascular Intervention

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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:

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06752096
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Navigantis Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Stroke, Meningioma, Neurovascular Disorder

Additional Details

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.

Arms & Interventions

Arms

Experimental: Robot Assisted Neurovascular Intervention

Patients will undergo robot-assisted neurovascular interventions.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul, Korea, Korea, Republic of

Status

Recruiting

Address

Severence Hospital, Yonsei University College of Medicine

Seoul, Korea,

Site Contact

Haena Kim

[email protected]

82-10-5008-1433

Clinical Trial Finder