Vascular Interventional Robotic System: The cerebral angiography will be performed by using the vascular interventional robotic system
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Angiography Success Rate — At the end of surgery Assessment of the success rate of the surgeon in completing cerebral angiography examination through the operation of vascular interventional robotic system or manual way.
Complication Rate — At the day after surgery Potential complications include: ① Directly related to the interventional procedure: Vascular injury (vessel rupture, perforation, spasm, gas embolism, and thrombosis); ② Neurological complications: New-onset neurological deficits (transient/permanent), new-onset cerebral ischemia, or new-onset intracerebral hemorrhage, confirmed by postoperative imaging; ③ Systemic complications: Cardiac events, gastrointestinal bleeding, renal dysfunction, etc.
Trial sites (2)
Facility
City
Region
Status
Beijing Tiantan Hospital, Capital Medical University
Beijing
Beijing Municipality
Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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