ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China

Acotec Scientific

Status: Completed

Conditions: Varicose Veins of Lower Limb

Treatments: Device: ERA-C70,ERA-C30 and ERA-G5; Device: ClosureFast™ and ClosureRFG™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04658901

ACOART RF CLOSURE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

test group

Experimental group

Description:

use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) made by Acotec Scientific Co.,Ltd.

Treatment:

Device: ERA-C70,ERA-C30 and ERA-G5

control group

Active Comparator group

Description:

use the ClosureRFG™ and ClosureFast™ made by Medtronic Inc.

Treatment:

Device: ClosureFast™ and ClosureRFG™