Efficacy and Safety of Medical Adhesive in the Treatment of Varicose Veins of the Lower Extremities: A Prospective, Multicenter, Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Clinical success rate
Study Overview
Brief Summary
The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.
The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.
Participants will:
Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.
Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically diagnosed as great saphenous vein varices. (This operation only dealt with one side varicose veins of the lower extremities.)
- •CEAP is graded C2-C
- •Doppler ultrasound confirmed the patency of deep veins of lower limbs.
- •Sign informed consent, voluntarily participate in the trial and follow up as required
Exclusion Criteria
- •A history of lower extremity deep vein thrombosis or pulmonary embolism
- •Recurrent varicose veins
- •The diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm
- •The great saphenous vein is severely distorted or tuberculated at the root
- •Sepsis or septicemia
- •Allergic to n-butyl cyanoacrylate
- •The distance between the skin and the target vessel wall of the great saphenous vein less than 5 mm
- •Severe cardiopulmonary disease, shock, coma or multiple organ failure
- •Lactating or pregnant women
- •Participated in other clinical trials within 1 month before surgery
- •The researchers considered it unsuitable for inclusion
Arms & Interventions
Medical Adhesive treatment group
Intervention: Medical Adhesive (Device)
Endovenous Radiofrequency Ablation Catheter
Intervention: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter (Device)
Outcomes
Primary Outcomes
Clinical success rate
Time Frame: 24 weeks after operation.
At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
Secondary Outcomes
- Target vascular closure rate at 12 weeks after operation.(12 weeks after operation.)
- Operation duration(Immediately after operation)
- Venous Clinical Severity Score (VCSS)(Screening period, 4 weeks, 12 weeks and 24 weeks after operation.)
- Technical success rate(Immediately after operation)
- Clinical signs(Screening period, 12 and 24 weeks after operation.)
- Aberdeen Varicose Vein Questionnaire (AVVQ)(Screening period, 4 weeks, 12 weeks and 24 weeks after operation.)
- Evaluation of product performance(within 24 hours after operation)
Investigators
Zhang Xiaoming
Chief physician of Vascular Surgery
Peking University People's Hospital