Cerebral Angiography
Conditions
Keywords
Cerebral Angiography, Interventional Surgical Robot
Brief summary
The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.
Interventions
DEVICEInterventional Robotic System
Cerebral angiography was performed by using the interventional robotic system
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 85 years; 2. Plan to undergo cerebral angiography; 3. Voluntarily participated in this trial and signed the informed consent form.
Exclusion criteria
1. Preoperative mRS score \>2; 2. Allergy or intolerance to iodine contrast media; 3. Allergy to interventional devices; 4. Severe cardiac, hepatic and renal insufficiency; 5. Active systemic infection; 6. Severe stenosis, occlusion or skin infection at the puncture site; 7. Subjects who are to undergo surgery at the same time as cerebral angiography; 8. Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin); 9. Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening; 10. Female subjects of childbearing age who are pregnant or breastfeeding; 11. Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate | at the end of surgery | Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Super-selective Catheterization Time for Target Vessels | at the end of surgery | Calculate and compare the average time taken to perform super-selective catheterization for each target vessel during each surgical procedure. |
| DSA Fluoroscopy Time | at the end of surgery | Record and compare the duration of fluoroscopy during DSA for each surgical procedure. |
| Super-selective Technique Success Rate | at the end of surgery | Assessing the technical success rate of the surgical physician in performing super-selective catheterization of cerebral vessels through the operation of experimental instruments or artificial means. |
| Primary Operator Radiation Absorbed Dose | at the end of surgery | Record and compare the absorbed dose of ionizing radiation received by the primary operator during each surgical procedure. |
| Instrument Performance Evaluation | at the end of surgery | The surgical physician fills out a form after the surgery to subjectively evaluate the performance of the experimental instruments during the angiographic examination procedure. |
| Surgical Time | at the end of surgery | Record and compare the duration of each surgical procedure. |
Countries
China
Outcome results
None listed