Crerbral Angiography
Conditions
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 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.
Interventions
The cerebral angiography will be performed by using the vascular interventional robotic system
Sponsors
Peking Union Medical College Hospital
Beijing Tiantan Hospital
The First Hospital of Hebei Medical University
The First Affiliated Hospital of Zhengzhou University
Tangshan Worker's Hospital
The Second Affiliated Hospital of Harbin Medical University
The First People's Hospital of Lianyungang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation Time | At the end of surgery | Record and compare the duration of each surgical procedure. |
| Super-selective Success Rate | At the end of surgery | Assessing the success rate of the surgeon in performing super-selective catheterization of each cerebral vessels through the operation of vascular interventional robotic system or manual way. |
| Super-selective Catheterization Time for Vessels | At the end of surgery | Calculate and compare the average time taken for surgeon to perform super-selective catheterization for each target vessel during each surgical procedure. |
| Digital Subtraction Angiography (DSA) Fluoroscopy Time | At the end of surgery | Calculate and compare the average time of fluoroscopy during cerebral angiography for each surgical procedure. |
| Primary Operator Radiation Absorbed Dose | At the end of surgery | Record and compare the absorbed dose of radiation received by the primary operator during each surgical procedure. |
| Participant Radiation Absorbed Dose | At the end of surgery | Record and compare the absorbed dose of radiation received by the participant during each surgical procedure. |
| Frequence of robotic operations transition to manual operations | At the end of surgery | Document the frequence where robotic operations transition to manual operations due to certain force majeure events. |
| Vascular Interventional Robotic System Performance Evaluation | At the end of surgery | The surgical physician rate a score (0-10) after the surgery to subjectively evaluate the performance of the vascular interventional robotic system during the angiographic examination procedure. |
| Operation Preparation Time | At the end of Surgery | Calculate and compare the time from when participants enter the operating room until the primary operator formal start the surgery. |
Countries
China
Outcome results
None listed