Robot-Assisted Neurovascular Intervention
Robot-assisted Neurovascular Intervention for Patients Indicated for Angiography, Cerebral Artery Embolization, and Thrombectomy: Exploratory Study to Compare to Existing Interventional Procedures
Navigantis Inc.
10 participants
Dec 27, 2024
INTERVENTIONAL
Conditions
Summary
Patients scheduled for neurovascular interventions may be eligible to have their procedure done robotically.
Eligibility
Inclusion Criteria1
- 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 Criteria15
- 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.
Interventions
This intervention will be conducted using robotic navigation.
Diagnostic cerebral angiogram will be performed using a robot to navigate guidewires and catheters to target vessels.
Meningioma tumors will be embolized using a robot to navigate catheters and wires to the target vessels to the tumor.
Mechanical thrombectomy procedure will use a robot to navigate catheters, guidewires, and thrombectomy devices to the target vessel.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06752096