A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Active, not recruiting

Conditions

Crerbral Angiography

Treatments

Device: Vascular Interventional Robotic System

Study type

Interventional

Funder types

Other

Identifiers

NCT07182188

MR-11-24-024538

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.