Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui Da and Medtronic) in Radiofrequency Ablation for Varicose Veins

NCT07046286 | Not Yet Recruiting

• 1 other identifier: ChengduUTCM10
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to systematically compare the clinical efficacy (venous closure rate and symptom relief rate), safety (perioperative and postoperative complications), and cost-effectiveness (direct medical costs) of domestic Xianruida radiofrequency catheter and imported Medtronic catheter in endovenous radiofrequency ablation for varicose veins through a single-center, prospective, non-inferiority randomized controlled trial.

Conditions

Varicose Veins of Lower Limb; Venous Insufficiency of Leg; Vascular Disease，Peripheral

Keywords

varicose veins of the great saphenous veins; radiofrequency ablation; catheters

Outcome Measures

Primary Outcomes (1)

• Venous Closure Rate at 12 Months Post-operation

  The venous closure rate confirmed by ultrasound 12 months after surgery, categorized as complete closure (no blood flow signal) or partial closure (blood flow signal \< 10 cm).This classification is used to determine the difference in the effect of achieving venous occlusion between the two catheters. Unit of Measure: Percentage of closed veins (%)

  12 months

Secondary Outcomes (9)

• Change in Aberdeen Varicose Vein Questionnaire (AVVQ) Score from

  3, 6, and 12 months

• Change in Venous Clinical Severity Score (VCSS) from Baseline

  3, 6, and 12 months

• Change in CIVIQ-20 Score from Baseline

  3, 6, and 12 months

• Number of Intraoperative Complications

  During surgery

• Number of Postoperative Complications within 30 Days

  12 months

Study Arms (2)

Experimental Group: Treatment of great saphenous vein varicosity using the Xianruida AcoArt Venous™

EXPERIMENTAL

Experimental group: Xianruida Endovenous Radiofrequency Ablation Catheter Participants will receive endovenous radiofrequency ablation (RFA) using the Xianruida catheter. The procedure includes catheter insertion into the target vein under ultrasound guidance. Data on surgery date, limb position, treatment length, and device performance will be recorded.

Procedure: Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.

Control Group: Treatment of great saphenous vein varicosity using the Medtronic ClosureFast™ endoven

ACTIVE COMPARATOR

Control group: Medtronic ClosureFast™ Endovenous Radiofrequency Ablation Catheter Participants will undergo RFA using the Medtronic ClosureFast™ catheter. The procedure is similar to the experimental arm, with the same temperature and withdrawal speed settings. Data collected will include surgery date, limb position, treatment length, and device performance.

Procedure: Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.

Interventions

Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins. PROCEDURE

1. Surgical Procedures: Standardized radiofrequency ablation (GSV/SSV closure) was carried out in both groups by the same team. Catheter parameters were set as 120°C and 1 cm/min withdrawal speed. The treatment segment of the great saphenous vein was required to be \>1 cm from the skin before anesthesia. For calf varicose veins, treatment was done after great saphenous vein ablation. * Experimental Group: Utilized Xianruida's catheter with advanced features. Surgical and device - related information was recorded. * Control Group: Used Medtronic's catheter. Similar data were recorded as in the experimental group. 2. Postoperative Management: Consistent for both groups. * Compression: Applied elastic bandage + Class II compression stockings. * Medication: Patients took oral anticoagulants and painkillers as needed, with usage details recorded during follow - up.

Control Group: Treatment of great saphenous vein varicosity using the Medtronic ClosureFast™ endoven; Experimental Group: Treatment of great saphenous vein varicosity using the Xianruida AcoArt Venous™

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years old.
• Clinically diagnosed with primary lower extremity varicose veins, with CEAP grade C2 - C5, and requiring treatment of the great saphenous vein segment.
• Doppler ultrasound confirms that the reflux time of the saphenofemoral vein valve is \> 1.0 second.
• Doppler ultrasound confirms that the diameter of the great saphenous vein in the supine position is \> 3mm and \< 12mm.
• Only one limb of each patient is included in the study.
• The patient signs the informed consent form and is willing to cooperate with the examinations and follow - ups specified in the protocol.

You may not qualify if:

• Thrombosis in the great saphenous vein, or combined with deep vein thrombosis, or a history of deep vein thrombosis or pulmonary embolism.
• Recurrent varicose veins after previous treatment.
• Severe tortuosity of the great saphenous vein, with the expectation that the catheter cannot pass through.
• Severe lower extremity ischemia (CLI).
• Known allergy to drugs or device materials involved in the study.
• History of cardiac pacemaker or defibrillator implantation.
• Pregnant or breastfeeding women.
• Currently participating in other drug or device studies.
• Deemed unsuitable for endovenous treatment by the researcher.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

Location

Related Publications (4)

• Farah MH, Nayfeh T, Urtecho M, Hasan B, Amin M, Sen I, Wang Z, Prokop LJ, Lawrence PF, Gloviczki P, Murad MH. A systematic review supporting the Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society guidelines on the management of varicose veins. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1155-1171. doi: 10.1016/j.jvsv.2021.08.011. Epub 2021 Aug 24.

  PMID: 34450355 BACKGROUND

• Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

  PMID: 21536172 BACKGROUND

• Zhai Y, Lu YM, Lu W, Yang C. Radiofrequency ablation of the great saphenous vein in the treatment of varicose veins of the lower extremities. Ann Ital Chir. 2022;93:235-240.

  PMID: 35503057 BACKGROUND

• Tang MJ, Zhou LY, Jia XJ, Wu JJ, Lou YB, Jin MJ, Zhu YF. [Randomized controlled study on the application effect of a new type of intravenous radiofrequency closed therapy system made in China and an imported system]. Zhonghua Wai Ke Za Zhi. 2024 Mar 1;62(3):223-228. doi: 10.3760/cma.j.cn112139-20231012-00167. Chinese.

  PMID: 38291638 BACKGROUND

Related Links

• Xianruida's endovenous radiofrequency ablation device for the treatment of varicose veins has been approved for marketing

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chunshui He, Doctor

CONTACT

86-18981885601; Chunshuihe@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vascular Surgery in ChengduUTCM

Model Details: According to the randomization results, the experimental group will use the endovenous radiofrequency ablation catheter produced by Xianruida Medical Technology Holdings Co., Ltd., while the control group will use the ClosureFast™ endovenous radiofrequency ablation catheter produced by Medtronic Inc. to perform the surgery. Surgical information (surgery date, limb position, distance from the treatment starting point to the saphenofemoral junction, treatment length), device usage information (device name and specifications, set power, set temperature, radiofrequency emission time), product performance evaluation, and immediate technical success will be recorded.

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: July 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)