A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

Post-Market Application Study and Efficacy/Safety Evaluation of a Vascular Interventional Robotic System for Cerebral Angiography: A Multicenter Randomized Controlled Trial

This study aims to conduct a post-market, multicenter clinical trial utilizing an interventional robotic system for cerebral angiography. By comparing it with traditional angiography procedures, the study will systematically evaluate the efficacy and safety of robot-assisted angiography in real clinical settings. Researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, complication rate, etc.

Inclusion Criteria:

1. Age between 18 and 75 years;
2. Suspected vascular lesions in the head and neck, or other conditions involving head and neck vessels requiring whole-brain angiography for definitive diagnosis or to aid treatment decisions. Including but not limited to: intracranial aneurysms, arteriovenous malformations, cavernous malformations, arteriovenous fistulas, Moyamoya disease, Moyamoya syndrome, subarachnoid hemorrhage, symptomatic intracranial artery stenosis/occlusion, stenosis/occlusion of the carotid/subclavian/vertebral arteries, acute/ chronic subdural hematoma, etc;
3. American Society of Anesthesiologists (ASA) physical status classification I-III (no severe cardiopulmonary dysfunction);
4. Patients who voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Patients who are to undergo surgery at the same time as cerebral angiography;
2. Renal dysfunction (serum creatinine > 133 μmol/L or estimated glomerular filtration rate < 60 mL/min/1.73 m²);
3. Patients with known allergy to iodinated contrast media;
4. Coagulation disorders (prothrombin time >16s, activated partial thromboplastin time >45s, or platelet count <100×10⁹/L);
5. Severe infection, skin ulceration, or vascular anatomical abnormalities at the puncture site (e.g., bilateral femoral artery occlusion);
6. Pregnant or lactating women;
7. Patients with severe cognitive impairment;
8. Patients with psychiatric disorders;
9. Patients unable to undergo head magnetic resonance imaging (MRI), e.g., those with metallic implants, claustrophobia, or other contraindications;
10. Patients with other severe advanced or terminal illnesses;
11. Patients currently participating in other clinical trials.