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Active Not Recruiting NCT07182188

A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

Conditions: Crerbral Angiography

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 660
Sponsor: Peking Union Medical College Hospital

Location: Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality

Summary

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.

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07182188). StuddyBuddy aggregates publicly available trial information.