Robot-Assisted Neurovascular Intervention

Navigantis Inc.

Status: Enrolling

Conditions: Meningioma; Stroke; Neurovascular Disorder

Treatments: Device: Meningioma embolization using robotic device.; Device: Mechanical thrombectomy for stroke using a robotic device.; Procedure: cerebral angiography, arterial embolization, thrombectomy; Device: Cerebral angiogram using robotic device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06752096

2024-2751-002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Robot Assisted Neurovascular Intervention

Experimental group

Description:

Patients will undergo robot-assisted neurovascular interventions.

Treatment:

Device: Cerebral angiogram using robotic device

Device: Mechanical thrombectomy for stroke using a robotic device.

Procedure: cerebral angiography, arterial embolization, thrombectomy

Device: Meningioma embolization using robotic device.