Robot-assisted versus manual transradial cerebral angiography
Official title: Comparison of Safety and Efficacy Between Robot-Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: A Prospective Randomized Controlled Trial
Run by The First Hospital of Hebei Medical University · NCT07696936 · Data updated 2026-11-12
A randomized study tests whether robot-assisted transradial cerebral angiography is as safe and effective as the manual approach in adults 18 to 80 undergoing diagnostic cerebral angiography.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 156 (estimated) |
| Sponsor | The First Hospital of Hebei Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Status | Recruiting |
| Started | November 30, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2029 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT07696936 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with suspected intracranial vascular lesions requiring cerebral DSA, who have a positive Allen's test and suitable radial artery anatomy.
✕Probably not a fit
Patients with contrast allergy, emergency cerebrovascular conditions requiring immediate DSA, or severe comorbidities may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, non-inferiority, open-label randomized trial comparing a robot-assisted angiography system to manual transradial cerebral DSA performed by experienced neurosurgeons. Independent blinded endpoint adjudication and blinded data analysts will be used. The study aims to measure safety and efficacy, including procedural accuracy and potential reductions in radiation exposure for operators. Enrollment planned is 156 participants at The First Hospital of Hebei Medical University. Eligible patients include adults 18–80 with suspected intracranial vascular pathology who meet vascular and vascular access criteria outlined in the protocol.
Why it matters
Potential benefit: If successful, robot-assisted angiography could reduce physician radiation exposure while maintaining diagnostic accuracy.
How similar studies have gone: Previous studies in interventional robotics suggest potential safety and technical feasibility, but non-inferiority evidence in cerebral DSA remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Recruiting
Study contacts
- Study coordinator: Conghui Li, PhD
- Email: 13363880072@163.com
- Phone: +8618633889708
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.