Back to resultsACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China
Primary Purpose
Varicose Veins of Lower Limb
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ERA-C70,ERA-C30 and ERA-G5
ClosureFast™ and ClosureRFG™
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring Varicose Veins of Lower Limb, radiofrequency ablation endovenous closure
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.
Sites / Locations
- The First Affiliated Hospital,Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
test group
control group
Arm Description
use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) made by Acotec Scientific Co.,Ltd.
use the ClosureRFG™ and ClosureFast™ made by Medtronic Inc.
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
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%
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%
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.
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.
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)
Full Information
NCT ID
NCT04658901
First Posted
November 4, 2020
Last Updated
August 17, 2022
Sponsor
Acotec Scientific Co., Ltd
Collaborators
Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04658901
Brief Title
ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China
Official Title
Endovenous Radiofrequency Closure Catheter and Endovenous Radiofrequency Closure Generator in the Treatment of Varicose Veins of Lower Extremity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
April 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acotec Scientific Co., Ltd
Collaborators
Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins of Lower Limb
Keywords
Varicose Veins of Lower Limb, radiofrequency ablation endovenous closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm Description
use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) made by Acotec Scientific Co.,Ltd.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
use the ClosureRFG™ and ClosureFast™ made by Medtronic Inc.
Intervention Type
Device
Intervention Name(s)
ERA-C70,ERA-C30 and ERA-G5
Intervention Description
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
Intervention Name(s)
ClosureFast™ and ClosureRFG™
Intervention Description
use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA
Primary Outcome Measure Information:
Title
Complete closure rate of great saphenous vein
Description
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 Outcome Measure Information:
Title
Device success rate
Description
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
Title
Immediate technical success rate
Description
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)
Title
venous clinical severity score
Description
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
Title
Aberdeen Varicose Vein Questionnaire
Description
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
Title
Evaluation of the use of devices
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongkun Zhang, MD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital,Zhejiang University School of Medicine
City
Zhejiang
Country
China
12. IPD Sharing Statement
Learn more about this trial
ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China
We'll reach out to this number within 24 hrs