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Clinical Trials in China / NCT07182188
Active, not recruiting Not applicable

A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

NCT07182188 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Not applicable
Started
2024-09-01
Last updated
2026-09-04

Condition(s) studied

Crerbral Angiography

Investigational drug(s) / intervention(s)

Vascular Interventional Robotic System

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)

Trial sites (2)

FacilityCityRegionStatus
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

More Peking Union Medical College Hospital trials in China

Official registry record

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.

View NCT07182188 on ClinicalTrials.gov ↗ ← All trials in China