Clinical Research Directory

Robot-Assisted vs Manual Transradial Cerebral Angiography

Sponsor: The First Hospital of Hebei Medical University

Summary

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-assisted transradial cerebral angiography is non-inferior to the standard manual approach in terms of safety and clinical success, while providing additional benefits for both patients and physicians. Who can participate? We plan to enroll 156 adult patients (aged 18-80 years) who meet the following criteria: Stable vital signs and eligible for routine cerebral angiography Suspected intracranial vascular lesions or need for evaluation of intracranial mass blood supply, confirmed by CTA/MRA Positive Allen's test and adequate radial artery diameter (assessed by ultrasound) Able to provide informed consent Patients will be excluded if they have contrast allergy, require emergency angiography, have severe organ dysfunction, are pregnant or breastfeeding, or refuse robot-assisted procedures. What will happen during the study? After providing informed consent, eligible participants will be randomly assigned to one of two groups in a 1:1 ratio: Robot-assisted group: Cerebral angiography will be performed using a dedicated cerebrovascular interventional robot system, with the physician operating from a remote, radiation-free room. Manual control group: Cerebral angiography will be performed by experienced neurosurgeons using the standard manual technique. During the procedure, researchers will record key metrics including: Technical and clinical success rates of angiography Total procedure time and radiation exposure for both patients and physicians Incidence of perioperative and postoperative complications (e.g., vascular injury, hematoma, contrast reaction) Participants will be followed until hospital discharge or their next scheduled interventional treatment, during which all adverse events and complications will be carefully documented. What are the potential risks and benefits? Potential benefits: Participants will receive high-standard cerebral angiography care, either via robot-assisted or manual operation, both of which are clinically approved methods. The study results may help establish robot-assisted technology as a safe, effective alternative for cerebrovascular diagnosis, which could reduce physician radiation exposure and improve procedural precision in the future. Potential risks: Standard risks associated with cerebral angiography, including contrast allergy, vascular spasm, dissection, or puncture-site hematoma. Very low risk of device-related complications, such as unintended robot movement, which will be mitigated by strict operator training and safety protocols. How will the data be analyzed? All data will be analyzed using SAS 9.4 or later software. The primary analysis will use a non-inferiority design to compare the clinical success rate between the two groups. Secondary analyses will compare complication rates, radiation exposure, procedure duration, patient comfort, and surgeon satisfaction. All statistical tests will be two-sided, with a p-value ≤ 0.05 considered statistically significant. This study is designed to provide robust evidence on the safety and efficacy of robot-assisted transradial cerebral angiography, with the ultimate goal of advancing minimally invasive cerebrovascular care and protecting healthcare workers from occupational radiation hazards.

Official title: Comparison of Safety and Efficacy Between Robot-Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: A Prospective Randomized Controlled Trial

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