Robot-Assisted Neurovascular Intervention

Last updated: January 14, 2026
Sponsor: Navigantis Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Brain Tumor

Blood Clots

Treatment

Mechanical thrombectomy for stroke using a robotic device.

cerebral angiography, arterial embolization, thrombectomy

Cerebral angiogram using robotic device

Clinical Study ID

NCT06752096
2024-2751-002
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Exclusion Criteria 1 (General):

  1. Patients who have undergone surgery within 4 weeks prior to study participation orhave not fully recovered from surgery.

  2. Patients who are pregnant or breastfeeding.

  3. Patients with existing or anticipated vasospasm, bleeding, or severe atheromatousdisease.

  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 superiorvena cava (SVC) syndrome, within 3 months prior to study participation, or withexisting heart disease.

  7. Patients unable to cooperate due to difficulty in expressing intent to the extentthat the procedure cannot proceed.

  8. Patients with severe or life-threatening comorbidities that could significantlyaffect symptom improvement or render the procedure unbeneficial.

  9. Patients with non-life-threatening comorbidities that prevent proper follow-up fortreatment.

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 timeexceeding 90 minutes from CT angiography to reperfusion.

  5. Patients suspected to have cerebral artery dissection or atherosclerosis as thecause of stroke.

  6. Patients where the intracranial occlusion is determined to be chronic based onclinical history, prior imaging, or clinical judgment.

Study Design

Total Participants: 10
Treatment Group(s): 4
Primary Treatment: Mechanical thrombectomy for stroke using a robotic device.
Phase:
Study Start date:
December 27, 2024
Estimated Completion Date:
December 02, 2026

Study 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.

Connect with a study center

  • Severence Hospital, Yonsei University College of MEdicine

    Seoul, Korea
    Korea, Republic of

    Site Not Available

  • Severence Hospital, Yonsei University College of Medicine

    Seoul 1835848, Korea
    South Korea

    Active - Recruiting

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