Varicose Veins of Lower Limb Clinical Trial
Official title:
Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
NCT number | NCT05914740 |
Other study ID # | K2022110 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 19, 2023 |
Est. completion date | July 30, 2024 |
In this project, an exploratory study was conducted to perform in situ venous valve remodeling in vivo, evaluate venous valve function after surgery and conduct regular follow-up, collect relevant ultrasonic data before, during and after surgery, and evaluate the safety and effectiveness of Ultrasound-guided percutaneous great saphenous vein valve functional remodeling.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | July 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age 18-80, gender unlimited - CEAP grading was C2-C5 patients - The patient was clinically diagnosed as a primary varicose great saphenous vein of lower extremity, and the ultrasound findings were great saphenous vein valve insufficiency (complete structure, normal shape, enlarged valve ring, Duration of reflux >0.5s), only unilateral varicose great saphenous vein was treated this time Exclusion Criteria: - Patients with target vessel diameter < 3mm - The final valve of the great saphenous vein was not clear or lost its normal shape on ultrasound - Patients with deep vein valvular insufficiency - The presence of thrombus or thrombophlebitis in the main trunk of great cryptic skin - Target diseased blood vessel had previously received surgical treatment - Patients with deep vein thrombosis or history of pulmonary distension embolism - Patients with active implants such as pacemakers or ICDs - Patients with severe abnormal liver and kidney function (more than three times the normal value) - Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome >, arteriovenous sputum, etc - Any serious or uncontrolled systemic disease (including poorly medicated hypertension, diabetes, and diseases with active bleeding signs or severe coagulopathy) - Patients with diseases that may make treatment and evaluation difficult (e.g., malignant arsine tumor, acute infectious diseases, sepsis, systemic intolerability of surgery, life expectancy less than 12 months, etc.) - Pregnant and lactating women, or those who planned to have children during the study period - Patients who have participated in clinical trials of other drugs or medical devices within the last 3 months - Anesthetist and other patients were deemed unsuitable for the study |
Country | Name | City | State |
---|---|---|---|
China | The Fourth Affiliated Hospital Zhejiang University School of Medicine | Yiwu | Zhejiang Procince |
Lead Sponsor | Collaborator |
---|---|
The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
China,
De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bast — View Citation
Muhlberger D, Brenner E, Frings N, Geier B, Mumme A, Reich-Schupke S, Steffen HP, Stenger D, Stucker M, Hummel T. Functional repair of the great saphenous vein by external valvuloplasty reduces the vein's diameter: 6-month results of a multicentre study. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Venous valve regurgitation or not | Under the calf compression test, the venous valves were observed for blood flow regurgitation signal | immediately after intervention | |
Primary | Venous valve regurgitation or not | Under the calf compression test, the venous valves were observed for blood flow regurgitation signal | 1 week after intervention | |
Primary | Venous valve regurgitation or not | Under the calf compression test, the venous valves were observed for blood flow regurgitation signal | 1 month after intervention | |
Primary | Venous valve regurgitation or not | Under the calf compression test, the venous valves were observed for blood flow regurgitation signal | 3 months after intervention | |
Primary | Venous valve regurgitation or not | Under the calf compression test, the venous valves were observed for blood flow regurgitation signal | 6 months after intervention | |
Primary | Venous valve regurgitation or not | Under the calf compression test, the venous valves were observed for blood flow regurgitation signal | 1 year after intervention | |
Primary | Changes in the duration of venous valve regurgitation | The duration of venous valve regurgitation was measured under calf compression test | immediately after intervention | |
Primary | Changes in the duration of venous valve regurgitation | The duration of venous valve regurgitation was measured under calf compression test | 1 week after intervention | |
Primary | Changes in the duration of venous valve regurgitation | The duration of venous valve regurgitation was measured under calf compression test | 1 month after intervention | |
Primary | Changes in the duration of venous valve regurgitation | The duration of venous valve regurgitation was measured under calf compression test | 3 months after intervention | |
Primary | Changes in the duration of venous valve regurgitation | The duration of venous valve regurgitation was measured under calf compression test | 6 months after intervention | |
Primary | Changes in the duration of venous valve regurgitation | The duration of venous valve regurgitation was measured under calf compression test | 1 year after intervention |
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