Endovascular Robotic-Assisted SystEm for Cerebral Angiography (ERASE): Rationale, Design, and Protocol of a Multicenter Randomized Controlled Trial

BackgroundNeurointerventional therapy is a cornerstone in managing head and neck vascular disorders, with cerebral angiography serving as its fundamental diagnostic and therapeutic backbone. However, manual cerebral angiography is associated with several inherent limitations. While existing robotic-assisted systems have shown promise in mitigating some of these issues, they face challenges such as limited compatibility, lengthy setup times, and a lack of high-quality real-world evidence. MethodsThe ERASE trial is a multicenter, prospective, randomized controlled trial (RCT). A total of 450 eligible patients will be enrolled from six comprehensive stroke centers in China and randomized 1:1 to either the robotic-assisted group or the control group. Both groups use the Seldinger technique for femoral/radial artery access. Operators undergo standardized training on the robotic system, and all patients are followed up at baseline, end of surgery, 24 hours postoperatively, and 7 days post-discharge. ResultsThe primary efficacy outcome is the clinical success rate. The primary safety outcome is the incidence of perioperative/postoperative complications (e.g., vascular perforation, dissection, pseudoaneurysm), serious adverse events, and device malfunctions. Secondary outcomes include technical failure rate, overall procedural time, pre-puncture setup time, target vessel super-selective catheterization time, digital subtraction angiography fluoroscopy time, participant radiation doses and contrast agent volume. A key safety endpoint is the rate of new asymptomatic cerebral infarctions detected via postoperative brain MRI-diffusion-weighted imaging. ConclusionsAs the RCT focusing on the YDHB-NS01 Ver 2.0 system, the ERASE trial addresses critical unmet needs in neurointerventional practice and will generate high-quality evidence for robotic-assisted cerebral angiography. Trial registration number: ClinicalTrials.gov NCT07182188. Clinical Perspective1) What Is New? This multicenter RCT evaluates the YDHB-NS01 Ver 2.0 robotic-assisted system and provides rigorous evidence on its safety and efficacy compared with manual cerebral angiography, while validating targeted design enhancements addressing prior systems shortcomings 2) What Are the Clinical Implications? The study s findings could standardize the clinical application of robotic-assisted cerebral angiography and inspire further research on refining robotic interventional workflows to improve patient outcomes and provider safety.