Robot-Assisted Neurovascular Intervention

Official title

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

Overview

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

Detailed 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.

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.

Primary outcome measures

• Success rate of target vessel access [Time frame: From enrollment through end of procedure.]

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):

• 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.

Exclusion Criteria 2 (Cerebral Ischemic Stroke Patient):

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

South Korea · 1 center

• Severence Hospital, Yonsei University College of Medicine — Seoul

Identifiers

NCT: NCT06752096 · 2024-2751-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗