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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChengdu University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

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

Treatment groups

200 Participants
are divided into 2 treatment groups