ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China

Study Overview
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Brief Summary
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The purpose of the RCT trial is to determine whether endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and ClosureRFG™ in treating varicose veins of lower extremity.

Detailed Description
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This trial is a prospective, multi-center, 1:1 randomized using endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator versus ClosureFast™ and ClosureRFG™ to treat varicose veins of lower extremity. And parimary endpoint is Complete closure rate of great saphenous vein at 6 months post-procedure.

Official Title
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Endovenous Radiofrequency Closure Catheter and Endovenous Radiofrequency Closure Generator in the Treatment of Varicose Veins of Lower Extremity

Conditions
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Varicose Veins of Lower Limb

Intervention / Treatment
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* Device: ERA-C70,ERA-C30 and ERA-G5
* Device: ClosureFast™ and ClosureRFG™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age Patients clinically diagnosed as primary varicose great saphenous veins of lower extremity. And unilateral superficial varicose veins of lower extremity will be treated in this procedure. Patients with CEAP classification as C2-C5. Voluntarily participate in this study and sign the informed consent form Exclusion Criteria: patients with target vein diameter < 2mm or > 15mm. the distance between the anterior wall of the vessel and the skin of the target vein under ultrasound is less than 0.5cm. patients with aneurysmal dilation at the saphenous femoral junction. patients with venous aneurysm (defined as venous hemangioma with a diameter greater than or equal to 2 times the diameter of the adjacent vein). thrombosis or thrombophlebitis in the trunk of great saphenous vein. the great saphenous vein is so tortuous that radiofrequency closure catheter cannot cross the vein trunk. patients with target diseased vessels who have received surgical treatment in the past. patients with deep venous thrombosis or a history of pulmonary embolism. patients with active implants such as pacemakers or ICD. patients with severe hepatic and renal dysfunction (ALT > normal upper limit 3 times; creatinine > 225umol/L). patients who are contraindications to anesthesia. patients with secondary varicose veins caused by deep venous thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome), arteriovenous fistula, etc. any serious or uncontrollable systemic disease (including uncontrolled hypertension, diabetes, active bleeding signs or severe coagulation disorders, etc.). patients with diseases that may cause difficulties in treatment and evaluation (such as malignant tumors, acute infectious diseases, septicemia, general intolerability of surgery, life expectancy less than 12 months, etc.). pregnant and lactating women, or those who had a planned birth during the study period. patients who have participated in clinical trials of other drugs or medical devices in the past 3 months. According to the judgement of the investigator, other situations that are not suitable for enrollment.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) made by Acotec Scientific Co.,Ltd. | Device: ERA-C70,ERA-C30 and ERA-G5<br>* use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity<br>|
| Active Comparator: control group<br>use the ClosureRFG™ and ClosureFast™ made by Medtronic Inc. | Device: ClosureFast™ and ClosureRFG™<br>* use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete closure rate of great saphenous vein | Closure is defined as Doppler ultrasound examination (including color flow, compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm. Recanalization is defined as openings along the treated segment exceeding 5 cm in length as detected by duplex ultrasound. Complete closure rate = the number of subjects with closure of target vein in the group / the total number of subjects in the group x100% | at 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate | Device success is defined as the catheter could be advanced to the target position and retrieved successfully in the radiofrequency treatment procedure. Device success rate = the number of subjects with successful device in this group/the total number of subjects in this group x100% | during procedure | 
| Immediate technical success rate | The technical success is defined as target vein closure. And closure is defined as Doppler ultrasound examination (including color flow,compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm. Recanalization is defined as openings along the treated segment exceeding 5 cm in length as detected by duplex ultrasound. Immediate technical success rate = the number of subjects successfully operated in this group/the total number of subjects in this group x100% | during procedure (Instantly after the catheter retrieved) | 
| venous clinical severity score | 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. | at 6 months post-procedure | 
| Aberdeen Varicose Vein Questionnaire | Changes from baseline in Aberdeen Varicose Vein Questionnaire (AVVQ) (0-33,higher scores mean a worse outcome) scores in outpatient services. The Aberdeen Varicose Vein questionnaire (AVVQ) with 14-question survey was used to determine the quality of life of patients with varicose veins both before and after surgery. | at 6 months post-procedure | 
| 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) | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Veins of Lower Limb, radiofrequency ablation endovenous closure