Status:
ACTIVE_NOT_RECRUITING
A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Crerbral Angiography
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 s...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years;
- 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;
- American Society of Anesthesiologists (ASA) physical status classification I-III (no severe cardiopulmonary dysfunction);
- Patients who voluntarily participate in this study and sign an informed consent form.
Exclusion
- Patients who are to undergo surgery at the same time as cerebral angiography;
- Renal dysfunction (serum creatinine \> 133 μmol/L or estimated glomerular filtration rate \< 60 mL/min/1.73 m²);
- Patients with known allergy to iodinated contrast media;
- Coagulation disorders (prothrombin time \>16s, activated partial thromboplastin time \>45s, or platelet count \<100×10⁹/L);
- Severe infection, skin ulceration, or vascular anatomical abnormalities at the puncture site (e.g., bilateral femoral artery occlusion);
- Pregnant or lactating women;
- Patients with severe cognitive impairment;
- Patients with psychiatric disorders;
- Patients unable to undergo head magnetic resonance imaging (MRI), e.g., those with metallic implants, claustrophobia, or other contraindications;
- Patients with other severe advanced or terminal illnesses;
- Patients currently participating in other clinical trials.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT07182188
Start Date
September 1 2024
End Date
April 30 2027
Last Update
September 23 2025
Active Locations (2)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
2
Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730