Robot-Assisted vs Manual Transradial Cerebral Angiography

1. Basic Study Information Study Title: Comparison of Safety and Efficacy betweenRobot‐Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: AProspective Randomized Controlled Trial Sponsor: The First Hospital of Hebei MedicalUniversity, Hebei Hospital of Xuanwu Hospital Performing Department: Department ofNeurosurgery, The First Hospital of Hebei Medical University Principal Investigator:Li Conghui Study Design: Single‐center, prospective, non‐inferiority, open‐labelrandomized controlled trial with independent blinded endpoint adjudication andblinded data analysts 2. Study Objectives To systematically investigate the safety and efficacy ofhigh‐precision robot‐assisted system for cerebral angiography via transradialapproach, evaluate its operational accuracy, expand the application scenarios ofcerebrovascular interventional surgical robots, provide precise and safe technicalsupport for the diagnosis and treatment of cerebrovascular diseases, and promote theinnovation and development of relevant high and new technologies. 3. Study Population 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 intracranialspace‐occupying lesions/qualification of tumors; Positive Allen's test; Ultrasoundshows radial artery diameter >2.0 mm, or <2.0 mm but still eligible for transradialangiography as evaluated by senior physicians.Exclusion Criteria Patients with contrast medium allergy; Patients with acutehemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, andpatients with unstable acute stroke; Patients with severe vascularmalformation/stenosis/occlusion, severe hepatic and renal insufficiency, severehypertension/hypotension, severe infection, coagulation dysfunction, severecardio‐cerebro‐pulmonary diseases, congestive heart failure; Pregnant/lactatingwomen and women planning to become pregnant within 1 year; Patients clinicallyineligible for cerebral DSA; Patients with fear of interventional robots and refusalof robot‐assisted angiography.Sample Size: A total of 156 cases, 78 cases in the experimental group(robot‐assisted group) and 78 cases in the control group (manual group) (74 casesper group in basic calculation, expanded considering a 5% loss rate). 4. Interventions Experimental Group: Robot‐assisted transradial cerebral DSA (applyingthe "Cerebrovascular Interventional Surgery Assisted Operating System" developed byYidu Medical, with full‐process remote compartment operation); Control Group: Manualtransradial cerebral DSA performed by experienced neurosurgeons. 5. Randomization and Blinding Randomization: Block randomization mode, led by anindependent third party (Randomization Management Group, non‐surgical/evaluationstaff); clinical medical staff are only responsible for screening, informed consentand surgery implementation. After assigning a unique number to enrolled patients,the clinical research coordinator (CRC) completes random grouping, and groupinginformation is confidentially filed.Blinding: Blinded outcome assessors (CRF recorders not involved in surgery), blindeddata analysts (groups coded as Group A/B during statistical analysis, decryptedafter analysis); an emergency unblinding mechanism is established, unblinding isallowed in case of serious adverse events, and data are marked separately afterunblinding. 6. Study Endpoints Primary Endpoints Technical success rate of intracranial majorvascular angiography: Accurate positioning of target vessels for angiography withqualified image quality; Clinical success rate of intracranial major vascularangiography: Completion of angiography for at least 4 supra‐aortic major arteries(bilateral common carotid arteries + bilateral subclavian arteries).Secondary Endpoints Incidence of various perioperative and postoperativecomplications; Total radiation dose received by patients and primary surgeons; Totalduration of the entire angiography process, robot installation time, and singleangiography duration of each intracranial vessel; Targeting accuracy of theoperation; Patient satisfaction and comfort; Surgeon learning curve;Cost‐effectiveness analysis. 7. Study Risks and Benefits Benefits Expand the application scope of robots and improvepatients' surgical comfort; Clarify the accuracy and reliability of robot‐assistedtransradial angiography, achieving a success rate comparable to manual angiography;Reduce occupational radiation damage to physicians and realize robot‐assisted remotecompartment "zero‐radiation" operation.Risks Routine risks of cerebral DSA: Cardiac events, cerebrovascular events, adversereactions to contrast medium, vascular rupture/thrombosis/spasm/dissection, puncturesite hematoma/pseudoaneurysm, etc.; Very low probability of device‐related risk:Vascular injury caused by unintended movement of the robot. 8. Follow‐up Plan Pre‐enrollment Visit: Demographic statistics, recording ofconcomitant medications, safety examinations (pregnancy test, vital signs, routineblood test, hepatic and renal function, four coagulation tests, electrocardiogram),verification of inclusion and exclusion criteria; Intraoperative Visit: Recording ofangiography success rate, each time node, total duration, adverse events,concomitant medications; Postoperative Visit: Follow‐up until patient discharge orbefore the next cerebrovascular interventional treatment, recording of perioperativeand postoperative complications, adverse events, concomitant medications. 9. Statistical Analysis Software: SAS version 9.4 and above; Test Criterion: Two‐sidedtest, P ≤ 0.05 is considered statistically significant; Analysis Populations: FullAnalysis Set (per intention‐to‐treat principle), Per‐Protocol Set, Safety AnalysisSet; Analysis Methods: Quantitative indicators are expressed as mean ± standarddeviation/median (interquartile range), analyzed by t‐test/Mann‐Whitney U test;categorical indicators are expressed as number/percentage, analyzed by Chi‐squaretest/Fisher's exact test; interim analysis (safety rules) and subgroup analysis(complex anatomy, surgeon experience) are set; sensitivity analysis for missing datais performed by worst/best‐case scenario method and multiple imputation method. 10. Trial Termination Criteria Occurrence of serious safety events; Major errors in thestudy protocol/serious deviations in implementation, making it impossible toevaluate efficacy; Poor efficacy/defects of the study device with no clinical value;Termination requested by the sponsor; Trial revoked by the administrativedepartment.