A prospective, multicenter, randomized, controlled, non-inferiority trial in which patients with great saphenous vein varicosities were treated with either the novel vein closure system (Shanghai Tendfo Medical Technology Co., Ltd.) or radiofrequency ablation (RFA).
This prospective, multicenter, randomized, controlled, non-inferiority trial will enroll 180 patients with great saphenous vein (GSV) varicosities across multiple qualified centers. Eligible patients who provide informed consent will be randomized 1:1 to receive either the experimental treatment with cyanoacrylate closure (CAC) ( the Varicose Vein Closure Adhesive System, Shanghai Tendfo Medical Technology Co., Ltd.) or the control treatment with radiofrequency ablation (RFA) (the ClosureRFG™ generator and ClosureFast™ catheter, Medtronic Inc.), resulting in 90 patients per group. Enrollment is expected to start in June 2023 and complete by the end of 2023. Follow-up visits will occur before discharge or at 7 days after surgery, and at months 1, 3, 6, and 12, with Doppler ultrasound assessments at months 1, 3, 6, and 12 after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
Endovenous delivery of adhesive to the target site in diseased GSV by a tube. Deliver the adhesive in segmental fashion, until the target vein was completely closed.
Endovenous insertion of the ClosureFast RFA catheter into a target site in diseased GSV. Heat is applied to the target vein using radiofrequency energy released by the ClosureRFG™ to ablate the target vein.
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The rate of participants with complete GSV closure
Complete closure was defined as Doppler ultrasound examination (including color flow, compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm in length.
Time frame: 3 months after surgery
The rate of participants with complete GSV closure
Complete closure was defined as Doppler ultrasound examination (including color flow, compression, and pulsed Doppler) showing closure along the entire treated target vein segment with no discrete segments of patency exceeding 5 cm in length.
Time frame: 1、6、12 months after surgery
Success rate of operation
Immediately after the operation, an ultrasound examination showed that the GSV had been closed.
Time frame: Immediately after surgery
Pain score
After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.
Time frame: Before discharge or 7 days after surgery
Performance evaluation of the novel vein closure system
The handling performance of the investigational device in the experimental group, comprising introducibility, accuracy, convenience, and compatibility, shall be evaluated by the investigator.
Time frame: During or after surgery
Ecchymosis evaluation
The investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis. The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site. The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria: 0 rating = no ecchymosis, 1. rating = less than 25% ecchymosis, 2. rating = 25-50% ecchymosis, 3. rating = 50-75% ecchymosis, 4. rating = 75-100% ecchymosis, 5. rating = extension of ecchymosis above or below the treated area.
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The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Jinhua, Zhejiang, China
Ruian People's Hospital
Ruian, Zhejiang, China
Time frame: Before discharge or 7 days after surgery
CEAP (Clinical - Etiology - Anatomy - Pathophysiology) classification
CEAP (Clinical - Etiology - Anatomy - Pathophysiology) classification is employed to characterize patients with chronic venous disorders. The clinical manifestations (C) are graded by the investigator based on clinical signs and symptoms of patients.
Time frame: Screening period and 1、3、6、12 months after surgery
Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30.
Time frame: Screening period and 1、3、6、12 months after surgery
Aberdeen Varicose Vein Questionnaire (AVVQ)
The Aberdeen Varicose Vein questionnaire (AVVQ) with 12-question survey was used to determine the quality of life of patients with varicose veins both before and after surgery (0=best quality of life; 100=worse quality of life).
Time frame: Screening period and 1、3、6、12 months after surgery
AE rates
Adverse events and serious adverse events, including deep vein thrombosis (DVT), clinically symptomatic pulmonary embolism (PE), sensory abnormalities, epidermal numbness (nerve injury), skin burns, skin ulcers, and infections/cellular tissue inflammation, etc.
Time frame: The day of surgery, before discharge, 7 days, 1 month, 3 months, 6 months and 12 months after surgery