Robot-assisted procedures for neurovascular conditions

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

This study is testing whether using robots to help with brain and blood vessel procedures can make them safer and more effective for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Navigantis Inc. (Industry-sponsored)
• Locations: 1 site (Seoul, Korea)
• Trial ID: NCT06752096 on ClinicalTrials.gov

What this trial studies

This study explores the use of robotic assistance in neurovascular interventions for patients scheduled for procedures such as cerebral angiography, arterial embolization for meningioma, and thrombectomy for ischemic stroke. The aim is to evaluate the feasibility and potential advantages of performing these interventions robotically compared to traditional manual methods. Eligible patients will undergo standard selection criteria for these procedures, ensuring safety and efficacy. The study will assess outcomes related to the robotic approach in treating various neurovascular disorders.

Who should consider this trial

Good fit: Ideal candidates are patients scheduled for neurovascular interventions like cerebral angiography, embolization for meningioma, or thrombectomy for stroke.

Not a fit: Patients with recent surgeries, severe atheromatous disease, or certain cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the precision and safety of neurovascular interventions, potentially leading to better patient outcomes.

How similar studies have performed: While robotic assistance in surgery is gaining traction, this specific application in neurovascular interventions is relatively novel and has not been extensively tested.

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:

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.

Where this trial is running

Seoul, Korea

• Severence Hospital, Yonsei University College of Medicine — Seoul, Korea, South Korea (Recruiting)

Study contacts

• Study coordinator: Ken Lock

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