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Robot-Assisted vs Manual Transradial Cerebral Angiography

RecruitingNAAges 18 Years - 80 YearsAllThe First Hospital of Hebei Medical University
NCT07696936 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, randomized controlled clinical trial designed to compare the safety and effectiveness of robot-assisted transradial cerebral angiography versus manual operation performed by experienced neurosurgeons. The study will be conducted at the Department of Neurosurgery, The First Hospital of Hebei Medical University, with a total sample size of 156 participants. Why is this study being done? Cerebral angiography is a key diagnostic procedure for cerebrovascular diseases, such as stroke, aneurysm, and vascular malformation. Traditionally, it is performed manually by interventional physicians, who are exposed to significant radiation during the procedure. Robot-assisted technology offers a potential solution by allowing doctors to operate from a separate, shielded room, which could greatly reduce occupational radiation exposure. This study aims to verify whether robot-assi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18 to 80 years, regardless of gender; * Stable vital signs, eligible for routine cerebral digital subtraction angiography (DSA); * Suspected intracranial vascular lesions (stenosis, aneurysm, malformation, etc.) by computed tomography angiography (CTA)/magnetic resonance angiography (MRA) requiring further confirmation, or need to clarify the blood supply of intracranial space-occupying lesions/qualification of tumors; * Positive Allen's test; * Ultrasound shows radial artery diameter \>2.0 mm, or \<2.0 mm but still eligible for transradial angiography as evaluated by senior physicians. Exclusion Criteria: * Patients with contrast medium allergy; * Patients with acute hemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, and patients with unstable acute stroke; * Patients with severe vascular malformation/stenosis/occlusion, severe hepatic and renal insufficiency, severe hypertension/hypotension, severe infection, coagulation dysfunction, severe cardio-cerebro-pulmonary diseases, congestive heart failure; * Pregnant/lactating women and women planning to become pregnant within 1 year; * Patients clinically ineligible for cerebral DSA; * Patients with fear of interventional robots and refusal of robot-assisted angiography.
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What it tests

  • Robot-assisted angiographic system
  • Manual controlled transradial artery angiography
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Where

1 site
The First Hospital of Hebei Medical University
Shijiazhuang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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