Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
- Enrollment
- 176
- Locations
- 5
- Primary Endpoint
- Vascular closure rate at 6 months after the operation
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the treatment of varicose veins.
Detailed Description
In this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (Hongyuan Endovenous Radiofrequency Ablation Closure System)and control group (Medtronic's ClosureFast™ Radiofrequency Ablation System) at 1:1. The effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-80 years old, no gender limit.
- •Great saphenous varicose, CEAP grade C2-C
- •The diameter of the diseased vein is ≥2mm, ≤15mm.
- •Expected survival period ≥ 6 months.
- •The informed consent form can be signed by the patient or the legal representative.
Exclusion Criteria
- •Are pregnant or breastfeeding.
- •Participating in clinical trials of other devices or drugs.
- •Deep vein thrombosis in the affected limb.
- •Uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/L).
- •Acute thrombosis in the main saphenous vein of the affected limb.
- •The investigator judged that it is not suitable to participate in the clinical trial.
Outcomes
Primary Outcomes
Vascular closure rate at 6 months after the operation
Time Frame: 6 months
Calculation method: completely closed patients / total cases of subjects in the same group x 100%. Definition of complete closure: Complete closure refers to ultrasound follow-up at 6 months after surgery that shows no blood flow in varicose veins.
Secondary Outcomes
- Technical success rate(6 months)
- CEAP(6 months)
- Evaluation of the use of devices(6 months)
- VCSS(6 months)