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

NCT07046286 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-01

No results posted yet for this study

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

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

  • Chengdu University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-01
Completion
2026-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046286 on ClinicalTrials.gov