Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the treatment of varicose veins.

Detailed Description
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In this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (Hongyuan Endovenous Radiofrequency Ablation Closure System)and control group (Medtronic's ClosureFast™ Radiofrequency Ablation System) at 1:1. The effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.

Official Title
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Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins

Conditions
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Varicose Veins

Intervention / Treatment
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* Device: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years old, no gender limit. Great saphenous varicose, CEAP grade C2-C6. The diameter of the diseased vein is ≥2mm, ≤15mm. Expected survival period ≥ 6 months. The informed consent form can be signed by the patient or the legal representative. Exclusion Criteria: Are pregnant or breastfeeding. Participating in clinical trials of other devices or drugs. Deep vein thrombosis in the affected limb. Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L). Acute thrombosis in the main saphenous vein of the affected limb. The investigator judged that it is not suitable to participate in the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovenous Radiofrequency Ablation Closure System<br> | Device: radiofrequency ablation<br>* ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients<br>|
| Active Comparator: ClosureFast™ Radiofrequency Ablation System<br> | Device: radiofrequency ablation<br>* ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular closure rate at 6 months after the operation | Calculation method: completely closed patients / total cases of subjects in the same group x 100%. Definition of complete closure: Complete closure refers to ultrasound follow-up at 6 months after surgery that shows no blood flow in varicose veins. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEAP | The CEAP is an elaborate scoring system for varicose veins and other disorders from venous insufficiency. It has been developed to determine the severity of the condition for diagnosis and treatment point of view. CEAP stands for: Clinical Etiopathological Anatomical Pathophysiological | 6 months | 
| Technical success rate | The device is delivered in place and withdrawn smoothly, and the target diseased blood vessel is immediately examined by ultrasound without blood flow. | 6 months | 
| Evaluation of the use of devices | For endovenous radiofrequency closure catheter: evaluation on the degree of device flexibility, crossability, accuracy, usability (subjective evaluation scale: excellent, good and poor) For endovenous radiofrequency closure generator: evaluation on applicability,accuracy of identifying catheter version, stability in the procedure(subjective evaluation: yes or no) | 6 months | 
| VCSS | Changes from baseline in venous clinical severity score (VCSS) (0-30, higher scores mean a worse outcome) in outpatient services. the VCSS was derived by the American Venous Forum from the CEAP classification and provides means by which clinical outcomes in venous disease can be monitored in time.Compared to the CEAP, VCSS is said to be more responsive to changes in disease severity, thus making it great for progressive rankings. It proved good inter and intra observer reproducibility and is often cited in quality of life assessments | 6 months |