Robot-Assisted Neurovascular Intervention

NCT06752096 — Not applicable, Recruiting, 10 participants, Navigantis Inc.

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

RegistryNCT06752096
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, device feasibility
Enrollment10 (Estimated)
SponsorNavigantis Inc. (Industry); collaborators: Severance Hospital, Yonsie University College of Medicine
ConditionsStroke, Meningioma, Neurovascular Disorder
Interventionscerebral angiography, arterial embolization, thrombectomy, Cerebral angiogram using robotic device, Meningioma embolization using robotic device., Mechanical thrombectomy for stroke using a robotic device. (Procedure, device)
Datesstart 2024-12-27, primary completion 2026-12-01 (estimated), completion 2026-12-02 (estimated), first posted 2024-12-30, last updated 2026-01-16
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials for Meningioma All trials of cerebral angiography, arterial embolization, thrombectomy All trials of Cerebral angiogram using robotic device

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Robot Assisted Neurovascular InterventionExperimentalProcedure: cerebral angiography, arterial embolization, thrombectomy; Device: Cerebral angiogram using robotic device; Device: Meningioma embolization using robotic device.; Device: Mechanical thrombectomy for stroke using a robotic device.Patients will undergo robot-assisted neurovascular interventions.
  • cerebral angiography, arterial embolization, thrombectomy (Procedure): This intervention will be conducted using robotic navigation.
  • Cerebral angiogram using robotic device (Device): Diagnostic cerebral angiogram will be performed using a robot to navigate guidewires and catheters to target vessels.
  • Meningioma embolization using robotic device. (Device): Meningioma tumors will be embolized using a robot to navigate catheters and wires to the target vessels to the tumor.
  • Mechanical thrombectomy for stroke using a robotic device. (Device): Mechanical thrombectomy procedure will use a robot to navigate catheters, guidewires, and thrombectomy devices to the target vessel.

+Outcome measures

Primary outcomes

  • Success rate of target vessel access [From enrollment through end of procedure.]: Measurement Parameters: The primary outcome assesses whether the Vasco Robotic system navigates catheter or other procedural devices successfully to the target vessel.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

FacilityCityCountryStatus
Severence Hospital, Yonsei University College of MedicineSeoul, KoreaSouth KoreaRecruiting