NCT05778214
Recruiting
Not Applicable
A Multi-Center, Randomized, Non-Inferiority, Prospective and Parallel-Group Trial to Evaluate the Safety and Efficacy of the Interventional Robotic System for Cerebral Angiography
ConditionsCerebral Angiography
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Angiography
- Sponsor
- Changhai Hospital
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Clinical Success Rate
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Jian-min Liu
Dean of the Department of Neurosurgery
Changhai Hospital
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 and ≤ 85 years;
- •Plan to undergo cerebral angiography;
- •Voluntarily participated in this trial and signed the informed consent form.
Exclusion Criteria
- •Preoperative mRS score \>2;
- •Allergy or intolerance to iodine contrast media;
- •Allergy to interventional devices;
- •Severe cardiac, hepatic and renal insufficiency;
- •Active systemic infection;
- •Severe stenosis, occlusion or skin infection at the puncture site;
- •Subjects who are to undergo surgery at the same time as cerebral angiography;
- •Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin);
- •Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening;
- •Female subjects of childbearing age who are pregnant or breastfeeding;
Outcomes
Primary Outcomes
Clinical Success Rate
Time Frame: 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 Outcomes
- Super-selective Catheterization Time for Target Vessels(at the end of surgery)
- Super-selective Technique Success Rate(at the end of surgery)
- Instrument Performance Evaluation(at the end of surgery)
- DSA Fluoroscopy Time(at the end of surgery)
- Surgical Time(at the end of surgery)
- Primary Operator Radiation Absorbed Dose(at the end of surgery)
Study Sites (1)
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