CompletedNCT04658901Updated Aug 18, 2022

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

An interventional study of ERA-C70,ERA-C30 and ERA-G5 and ClosureFast™ and ClosureRFG™ in Varicose Veins of Lower Limb, sponsored by Acotec Scientific Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-18.

Sponsored by Acotec Scientific Co., Ltd · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 188
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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 studied

Varicose Veins of Lower Limb

Browse trials for

Varicose Veins 253

Keywords

Varicose Veins of Lower Limb
radiofrequency ablation endovenous closure

In context

Varicose Veins

253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.

This study's enrollment of 188 is above the median of 104 across 162 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

Acotec Scientific Co., Ltd is the lead sponsor of 17 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 188 participants (actual)

Study arms

Experimental
test group
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
Active comparator
control group
use the ClosureRFG™ and ClosureFast™ made by Medtronic Inc.
Device: ClosureFast™ and ClosureRFG™

Interventions

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

What researchers measure

Primary outcomes

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%
Time frame: at 6 months post-procedure

Secondary outcomes

Device success rate
Device success is defined as the catheter could be advanced to the target position and retrieved successfully in the radiofrequency treatment procedure. Device success rate = the number of subjects with successful device in this group/the total number of subjects in this group x100%
Time frame: during procedure
Immediate technical success rate
The technical success is defined as target vein closure. And 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. Immediate technical success rate = the number of subjects successfully operated in this group/the total number of subjects in this group x100%
Time frame: during procedure (Instantly after the catheter retrieved)
venous clinical severity score
Changes from baseline in venous clinical severity score (VCSS) (0-30, higher scores mean a worse outcome) in outpatient services. the VCSS was derived by the American Venous Forum from the CEAP classification and provides means by which clinical outcomes in venous disease can be monitored in time.Compared to the CEAP, VCSS is said to be more responsive to changes in disease severity, thus making it great for progressive rankings. It proved good inter and intra observer reproducibility and is often cited in quality of life assessments.
Time frame: at 6 months post-procedure
Aberdeen Varicose Vein Questionnaire
Changes from baseline in Aberdeen Varicose Vein Questionnaire (AVVQ) (0-33,higher scores mean a worse outcome) scores in outpatient services. The Aberdeen Varicose Vein questionnaire (AVVQ) with 14-question survey was used to determine the quality of life of patients with varicose veins both before and after surgery.
Time frame: at 6 months post-procedure
Evaluation of the use of devices
For endovenous radiofrequency closure catheter: evaluation on the degree of device flexibility, crossability, accuracy, usability (subjective evaluation scale: excellent, good and poor) For endovenous radiofrequency closure generator: evaluation on applicability,accuracy of identifying catheter version, stability in the procedure(subjective evaluation: yes or no)
Time frame: during procedure

Study locations

1 site

The First Affiliated Hospital,Zhejiang University School of Medicine
Zhejiang, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04658901
Lead sponsor: Acotec Scientific Co., Ltd
Collaborators: Zhejiang University
Responsible party: Sponsor
First posted: Dec 9, 2020
Start date: May 18, 2021
Primary completion: Jan 1, 2022
Completion: Apr 12, 2022
Last update: Aug 18, 2022

Study contacts

Hongkun Zhang, MD

principal investigator · Zhejiang University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Varicose Veins→

Other studies from this sponsor

Acotec Scientific Co., Ltd

Start the discussion