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

NCT04658901 | Completed

• 1 other identifier: ACOART RF CLOSURE
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins of Lower Limb

Keywords

Varicose Veins of Lower Limb; radiofrequency ablation endovenous closure

Outcome Measures

Primary Outcomes (1)

• Complete closure rate of great saphenous vein

  Closure is 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. Recanalization is defined as openings along the treated segment exceeding 5 cm in length as detected by duplex ultrasound. Complete closure rate = the number of subjects with closure of target vein in the group / the total number of subjects in the group x100%

  at 6 months post-procedure

Secondary Outcomes (5)

• Device success rate

  during procedure

• Immediate technical success rate

  during procedure (Instantly after the catheter retrieved)

• venous clinical severity score

  at 6 months post-procedure

• Aberdeen Varicose Vein Questionnaire

  at 6 months post-procedure

• Evaluation of the use of devices

  during procedure

Study Arms (2)

test group

EXPERIMENTAL

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

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

control group

ACTIVE COMPARATOR

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

Device: ClosureFast™ and ClosureRFG™

Interventions

ERA-C70,ERA-C30 and ERA-G5 DEVICE

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

test group

ClosureFast™ and ClosureRFG™ DEVICE

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

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead
• Zhejiang University: collaborator

Study Sites (1)

The First Affiliated Hospital,Zhejiang University School of Medicine

Zhejiang, China

Location

Study Officials

• Hongkun Zhang, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: December 9, 2020
• Study Start: May 18, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 12, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-07

Locations

CN (1)