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

NCT ID: NCT04658901

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2022-04-12

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.

Conditions

Varicose Veins of Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

test group

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

Group Type: EXPERIMENTAL

ERA-C70,ERA-C30 and ERA-G5

Intervention Type: DEVICE

use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity

control group

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

Group Type: ACTIVE_COMPARATOR

ClosureFast™ and ClosureRFG™

Intervention Type: DEVICE

use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA

Interventions

ERA-C70,ERA-C30 and ERA-G5

use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity

Intervention Type: DEVICE

ClosureFast™ and ClosureRFG™

use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

Acotec Scientific Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongkun Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The First Affiliated Hospital,Zhejiang University School of Medicine

Zhejiang, , China

Countries

China

Other Identifiers

ACOART RF CLOSURE

Identifier Type: -

Identifier Source: org_study_id