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