Clinical trial NCT04658901: ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China
Official title: Endovenous Radiofrequency Closure Catheter and Endovenous Radiofrequency Closure Generator in the Treatment of Varicose Veins of Lower Extremity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins of Lower Limb
Keywords: Varicose Veins of Lower Limb
radiofrequency ablation endovenous closure
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang University
First posted: 2020-12-09
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the RCT trial is to determine whether endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and ClosureRFG™ in treating varicose veins of lower extremity.

Detailed description: This trial is a prospective, multi-center, 1:1 randomized using endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator versus ClosureFast™ and ClosureRFG™ to treat varicose veins of lower extremity. And parimary endpoint is Complete closure rate of great saphenous vein at 6 months post-procedure.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age
* Patients clinically diagnosed as primary varicose great saphenous veins of lower extremity. And unilateral superficial varicose veins of lower extremity will be treated in this procedure.
* Patients with CEAP classification as C2-C5.
* Voluntarily participate in this study and sign the informed consent form

Exclusion Criteria:

* patients with target vein diameter \< 2mm or \> 15mm.
* the distance between the anterior wall of the vessel and the skin of the target vein under ultrasound is less than 0.5cm.
* patients with aneurysmal dilation at the saphenous femoral junction.
* patients with venous aneurysm (defined as venous hemangioma with a diameter greater than or equal to 2 times the diameter of the adjacent vein).
* thrombosis or thrombophlebitis in the trunk of great saphenous vein.
* the great saphenous vein is so tortuous that radiofrequency closure catheter cannot cross the vein trunk.
* patients with target diseased vessels who have received surgical treatment in the past.
* patients with deep venous thrombosis or a history of pulmonary embolism.
* patients with active implants such as pacemakers or ICD.
* patients with severe hepatic and renal dysfunction (ALT \> normal upper limit 3 times; creatinine \> 225umol/L).
* patients who are contraindications to anesthesia.
* patients with secondary varicose veins caused by deep venous thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome), arteriovenous fistula, etc.
* any serious or uncontrollable systemic disease (including uncontrolled hypertension, diabetes, active bleeding signs or severe coagulation disorders, etc.).
* patients with diseases that may cause difficulties in treatment and evaluation (such as malignant tumors, acute infectious diseases, septicemia, general intolerability of surgery, life expectancy less than 12 months, etc.).
* pregnant and lactating women, or those who had a planned birth during the study period.
* patients who have participated in clinical trials of other drugs or medical devices in the past 3 months.
* According to the judgement of the investigator, other situations that are not suitable for enrollment.

Primary outcomes:
measure: Complete closure rate of great saphenous vein
timeFrame: at 6 months post-procedure
Secondary outcomes:
measure: Device success rate
timeFrame: during procedure
measure: Immediate technical success rate
timeFrame: during procedure (Instantly after the catheter retrieved)
measure: venous clinical severity score
timeFrame: at 6 months post-procedure
measure: Aberdeen Varicose Vein Questionnaire
timeFrame: at 6 months post-procedure
measure: Evaluation of the use of devices
timeFrame: during procedure
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: The First Affiliated Hospital,Zhejiang University School of Medicine
Study officials:
affiliation: Zhejiang University
name: Hongkun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: