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Varicose Veins of Lower LimbNCT04658901

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

A study testing ERA-C70,ERA-C30 and ERA-G5 and ClosureFast™ and ClosureRFG™ in people with Varicose Veins of Lower Limb, run by Acotec Scientific Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Varicose Veins of Lower Limb
What is being tested?
ERA-C70,ERA-C30 and ERA-G5 and ClosureFast™ and ClosureRFG™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteChina
Study dates
18 May 2021to 12 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 17Show fewer
  • 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 locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital,Zhejiang University School of Medicine

    Zhejiang

Other trials in China

About this study

Official title: Endovenous Radiofrequency Closure Catheter and Endovenous Radiofrequency Closure Generator in the Treatment of Varicose Veins of Lower Extremity

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.

Being tested
ERA-C70,ERA-C30 and ERA-G5, ClosureFast™ and ClosureRFG™
Keywords
Varicose Veins of Lower Limb, radiofrequency ablation endovenous closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERA-C70,ERA-C30 and ERA-G5Device

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

  • ClosureFast™ and ClosureRFG™Device

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

Study groups in NCT04658901
Study groupRoleWhat they receive
test groupExperimentaluse endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) made by Acotec Scientific Co.,Ltd.
Receives: Device: ERA-C70,ERA-C30 and ERA-G5
control groupActive comparatoruse the ClosureRFG™ and ClosureFast™ made by Medtronic Inc.
Receives: Device: ClosureFast™ and ClosureRFG™

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%

    Measured: at 6 months post-procedure

Secondary outcomes (5)

  1. 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%

    Measured: during procedure

  2. 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%

    Measured: during procedure (Instantly after the catheter retrieved)

  3. 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.

    Measured: at 6 months post-procedure

  4. 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.

    Measured: at 6 months post-procedure

  5. 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)

    Measured: during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start18 May 2021
  3. Primary completion1 Jan 2022
  4. Study completion12 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04658901
Sponsor's protocol ID
ACOART RF CLOSURE
Status last verified
Jul 2022
First submitted
4 Nov 2020
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shang T, Zhu YF, Jiang JS, He J, Yang J, Tian L, Wang XH, He YY, Zhu QQ, Wu ZH, Li DL, Zhang HK. A multicenter randomized controlled trial evaluating a new radiofrequency ablation system in the treatment of primary great saphenous vein incompetence: Six-month results of the ACOART RF CLOSURE study. Phlebology. 2026 Feb 24:2683555261426651. doi: 10.1177/02683555261426651. Online ahead of print.

    PubMed 41733281

Questions about this trial

What is this clinical trial studying?

A study testing ERA-C70,ERA-C30 and ERA-G5 and ClosureFast™ and ClosureRFG™ in people with Varicose Veins of Lower Limb, run by Acotec Scientific Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete closure rate of great saphenous vein (time frame: at 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04658901, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.

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