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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) made by Acotec Scientific Co.,Ltd. |
|
| control group | Active Comparator | use the ClosureRFG™ and ClosureFast™ made by Medtronic Inc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERA-C70,ERA-C30 and ERA-G5 | Device | use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongkun Zhang, MD | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,Zhejiang University School of Medicine | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41733281 | Derived | Shang T, Zhu YF, Jiang JS, He J, Yang J, Tian L, Wang XH, He YY, Zhu QQ, Wu ZH, Li DL, Zhang HK. A multicenter randomized controlled trial evaluating a new radiofrequency ablation system in the treatment of primary great saphenous vein incompetence: Six-month results of the ACOART RF CLOSURE study. Phlebology. 2026 Feb 24:2683555261426651. doi: 10.1177/02683555261426651. Online ahead of print. |
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| ClosureFast™ and ClosureRFG™ | Device | use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA |
|
| 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 |