Endovenous Radiofrequency Closure Catheter and Endovenous Radiofrequency Closure Generator in the Treatment of Varicose Veins of Lower Extremity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins of Lower Limb
- Sponsor
- Acotec Scientific Co., Ltd
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Complete closure rate of great saphenous vein
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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-C
- •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).
Outcomes
Primary Outcomes
Complete closure rate of great saphenous vein
Time Frame: at 6 months post-procedure
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 Outcomes
- venous clinical severity score(at 6 months post-procedure)
- Device success rate(during procedure)
- Immediate technical success rate(during procedure (Instantly after the catheter retrieved))
- Aberdeen Varicose Vein Questionnaire(at 6 months post-procedure)
- Evaluation of the use of devices(during procedure)