A Clinical Trial for the Interventional Robotic System

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cerebral Angiography

Intervention / Treatment
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* Device: Interventional Robotic System


Participation Criteria
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Eligibility Criteria
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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; Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Robotic System Assisted Surgery<br>Experimental group underwent cerebral angiography using the vascular interventional surgical control system | Device: Interventional Robotic System<br>* Cerebral angiography was performed by using the interventional robotic system<br>|
| No Intervention: Traditional Manual Surgery<br>The control group process the traditional manual operation for cerebral angiography | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success Rate | Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means. | at the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Super-selective Technique Success Rate | 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. | at the end of surgery | 
| Super-selective Catheterization Time for Target Vessels | Calculate and compare the average time taken to perform super-selective catheterization for each target vessel during each surgical procedure. | at the end of surgery | 
| DSA Fluoroscopy Time | Record and compare the duration of fluoroscopy during DSA for each surgical procedure. | at the end of surgery | 
| Surgical Time | Record and compare the duration of each surgical procedure. | at the end of surgery | 
| Primary Operator Radiation Absorbed Dose | Record and compare the absorbed dose of ionizing radiation received by the primary operator during each surgical procedure. | at the end of surgery | 
| Instrument Performance Evaluation | The surgical physician fills out a form after the surgery to subjectively evaluate the performance of the experimental instruments during the angiographic examination procedure. | at the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Angiography, Interventional Surgical Robot