Robot-Assisted vs Manual Transradial Cerebral Angiography

• Basic Study Information Study Title: Comparison of Safety and Efficacy between Robot-Assisted and Manual Transradial Cerebral Digital Subtraction Angiography: A Prospective Randomized Controlled Trial Sponsor: The First Hospital of Hebei Medical University, Hebei Hospital of Xuanwu Hospital Performing Department: Department of Neurosurgery, The First Hospital of Hebei Medical University Principal Investigator: Li Conghui Study Design: Single-center, prospective, non-inferiority, open-label randomized controlled trial with independent blinded endpoint adjudication and blinded data analysts
• Study Objectives To systematically investigate the safety and efficacy of high-precision robot-assisted system for cerebral angiography via transradial approach, evaluate its operational accuracy, expand the application scenarios of cerebrovascular interventional surgical robots, provide precise and safe technical support for the diagnosis and treatment of cerebrovascular diseases, and promote the innovation and development of relevant high and new technologies.
• 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 intracranial space-occupying lesions/qualification of tumors; Positive Allen's test; Ultrasound shows radial artery diameter >2.0 mm, or <2.0 mm but still eligible for transradial angiography as evaluated by senior physicians.

Exclusion criteria

Patients with contrast medium allergy; Patients with acute hemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, and patients with unstable acute stroke; Patients with severe vascular malformation/stenosis/occlusion, severe hepatic and renal insufficiency, severe hypertension/hypotension, severe infection, coagulation dysfunction, severe cardio-cerebro-pulmonary diseases, congestive heart failure; Pregnant/lactating women and women planning to become pregnant within 1 year; Patients clinically ineligible for cerebral DSA; Patients with fear of interventional robots and refusal of 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 cases per group in basic calculation, expanded considering a 5% loss rate).

• Interventions Experimental Group: Robot-assisted transradial cerebral DSA (applying the "Cerebrovascular Interventional Surgery Assisted Operating System" developed by Yidu Medical, with full-process remote compartment operation); Control Group: Manual transradial cerebral DSA performed by experienced neurosurgeons.
• Randomization and Blinding Randomization: Block randomization mode, led by an independent third party (Randomization Management Group, non-surgical/evaluation staff); clinical medical staff are only responsible for screening, informed consent and surgery implementation. After assigning a unique number to enrolled patients, the clinical research coordinator (CRC) completes random grouping, and grouping information is confidentially filed.

Blinding: Blinded outcome assessors (CRF recorders not involved in surgery), blinded data analysts (groups coded as Group A/B during statistical analysis, decrypted after analysis); an emergency unblinding mechanism is established, unblinding is allowed in case of serious adverse events, and data are marked separately after unblinding.

• Study Endpoints Primary Endpoints Technical success rate of intracranial major vascular angiography: Accurate positioning of target vessels for angiography with qualified image quality; Clinical success rate of intracranial major vascular angiography: 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 postoperative complications; Total radiation dose received by patients and primary surgeons; Total duration of the entire angiography process, robot installation time, and single angiography duration of each intracranial vessel; Targeting accuracy of the operation; Patient satisfaction and comfort; Surgeon learning curve; Cost-effectiveness analysis.

• Study Risks and Benefits Benefits Expand the application scope of robots and improve patients' surgical comfort; Clarify the accuracy and reliability of robot-assisted transradial angiography, achieving a success rate comparable to manual angiography; Reduce occupational radiation damage to physicians and realize robot-assisted remote compartment "zero-radiation" operation.

Risks Routine risks of cerebral DSA: Cardiac events, cerebrovascular events, adverse reactions to contrast medium, vascular rupture/thrombosis/spasm/dissection, puncture site hematoma/pseudoaneurysm, etc.; Very low probability of device-related risk: Vascular injury caused by unintended movement of the robot.

• Follow-up Plan Pre-enrollment Visit: Demographic statistics, recording of concomitant medications, safety examinations (pregnancy test, vital signs, routine blood test, hepatic and renal function, four coagulation tests, electrocardiogram), verification of inclusion and exclusion criteria; Intraoperative Visit: Recording of angiography success rate, each time node, total duration, adverse events, concomitant medications; Postoperative Visit: Follow-up until patient discharge or before the next cerebrovascular interventional treatment, recording of perioperative and postoperative complications, adverse events, concomitant medications.
• Statistical Analysis Software: SAS version 9.4 and above; Test Criterion: Two-sided test, P ≤ 0.05 is considered statistically significant; Analysis Populations: Full Analysis Set (per intention-to-treat principle), Per-Protocol Set, Safety Analysis Set; Analysis Methods: Quantitative indicators are expressed as mean ± standard deviation/median (interquartile range), analyzed by t-test/Mann-Whitney U test; categorical indicators are expressed as number/percentage, analyzed by Chi-square test/Fisher's exact test; interim analysis (safety rules) and subgroup analysis (complex anatomy, surgeon experience) are set; sensitivity analysis for missing data is performed by worst/best-case scenario method and multiple imputation method.
• Trial Termination Criteria Occurrence of serious safety events; Major errors in the study protocol/serious deviations in implementation, making it impossible to evaluate efficacy; Poor efficacy/defects of the study device with no clinical value; Termination requested by the sponsor; Trial revoked by the administrative department.

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 intracranial space-occupying lesions/qualification of tumors;
• Positive Allen's test;
• Ultrasound shows radial artery diameter >2.0 mm, or <2.0 mm but still eligible for transradial angiography as evaluated by senior physicians.

Exclusion criteria

• Patients with contrast medium allergy;
• Patients with acute hemorrhagic/ischemic cerebrovascular disease requiring emergency cerebral DSA, and patients with unstable acute stroke;
• Patients with severe vascular malformation/stenosis/occlusion, severe hepatic and renal insufficiency, severe hypertension/hypotension, severe infection, coagulation dysfunction, severe cardio-cerebro-pulmonary diseases, congestive heart failure;
• Pregnant/lactating women and women planning to become pregnant within 1 year;
• Patients clinically ineligible for cerebral DSA;
• Patients with fear of interventional robots and refusal of robot-assisted angiography.