Robot-Assisted Neurovascular Intervention

Launched by NAVIGANTIS INC. · Dec 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the use of robotic assistance during certain medical procedures for patients with conditions like stroke, meningioma (a type of brain tumor), and other neurovascular disorders. If you are someone who is scheduled for a procedure such as a diagnostic test to examine blood flow in the brain, treatment for a brain tumor, or a procedure to remove a blood clot, you may be eligible to participate in this trial. The study is currently recruiting participants aged 65 to 74 or 29 to 219 (which seems like a typo, likely meant to be 19) and is open to all genders.

If you decide to take part, you can expect that your procedure might be performed using advanced robotic technology, which could help make the process more precise. However, not everyone can participate; for example, if you are pregnant, have certain heart conditions, or have had recent surgeries, you may not be eligible. Additionally, the trial has specific guidelines to ensure patient safety, so if you have certain health issues or complications related to your condition, you might not be able to join. Overall, this trial aims to explore how robotic assistance can improve care during critical neurovascular interventions.

Gender

ALL

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.