Background: At present, neurointerventional surgery requires angiographers to perform operations in the digital subtraction angiography (DSA) room. Ionising radiation and chronic joint damage are still unavoidable for angiographers. Therefore, we researched and developed a neurointerventional robot-assisted system, which is operated by angiographers in an operating room outside the DSA room. We have conducted a prospective, multicentre, randomised controlled trial to evaluate the safety and efficacy of a robot-assisted system in human cerebral angiography. In the future, this research will provide a platform for the research and development of an intelligent surgical system and bring revolutionary progress in neurointerventional surgery.
Methods: From December 2020 to December 2021, 260 patients were enrolled from three medical centres, who were randomly and equally divided into a robot-assisted system group and a clinical routine cerebral angiography group. The success rate of angiography, the rate of the catheter reaching the target vessel, the operation time, X-ray radiation exposure and the incidence of related adverse events were compared between the two groups.
Results: A total of 257 patients completed this trial; baseline characteristics of the two groups did not differ significantly. The success rate of angiography in both the control group and the experimental group was 100%. The rate of the catheter reaching the target vessel was 99.23% and 100.00% in the control and experimental groups, respectively. For the control versus experimental groups, the angiographic operation time was 48.59±25.60 min versus 47.94±27.49 min, respectively; the X-ray radiation dose was 735.01±554.77 mGy versus 821.65±705.45 mGy, respectively; and the incidence of adverse events was 23.44% versus 22.48%, respectively. No statistical differences were present between the two groups.
Conclusion: The robot-assisted surgical system is more convenient for cerebral angiography and is as safe and effective as the traditional cerebral angiography.
Keywords: Angiography; Brain; Clinical Trial; Equipment and Supplies; Technology.
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