Safety and efficacy of cerebral robot assisted angiography: randomized comparison of robotic versus manual procedures.

Abstract

While robotic assisted technology has advanced in cardiovascular interventions, neurovascular applications still lack a robotic system. To assess the safety and efficacy of novel robotic systems designed for cerebral angiography, we conducted a multicenter, randomized controlled non-inferiority trial. 130 patients were recruited who received cerebral angiography in four centers. After identifying the target vessels, patients were randomly allocated to an experimental group for robotic procedures and a control group for manual procedures in a 1:1 ratio. Clinical success rate, technical success rate, overall surgery time, pre-puncture set-up time, puncture-to-unsheathed time, mean catheterization time per target vessel, X-ray fluoroscopy time, and primary operator's radiation dose were compared. The safety endpoints were incidence of perioperative vascular injuries, any adverse events, and device malfunctions. 64 patients were assigned to the experimental group and 66 to the control group. Both groups achieved 100% clinical success and a 100% technical success. Significantly, the primary operator's radiation dose in the robotic group was lower than that in the manual group (1.67±3.49 μSv vs 43.63±38.95 μSv, P<0.001). The puncture-to-unsheathed time (P=0.882), mean catheterization time per target vessel (P=0.247), and fluoroscopy time (P=0.701) were comparable. The pre-puncture set-up time in the robotic group was longer (P<0.001), attributed to prolonged robotic instrument set-up. No robot related adverse events were observed. The trial showed that the robotic system was safe and effective for assisting cerebral angiography, notably reducing primary operators' radiation exposure. ClinicalTrials.gov NCT05778214.