Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve

NCT05914740 | Unknown

• 1 other identifier: K2022110
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicose Veins of Lower Limb

Keywords

Varicose veins in the lower extremities; Ultrasonic guidance; venous valve of Lower limb

Outcome Measures

Primary Outcomes (12)

• Venous valve regurgitation or not

  Under the calf compression test, the venous valves were observed for blood flow regurgitation signal

  immediately after intervention

• Venous valve regurgitation or not

  Under the calf compression test, the venous valves were observed for blood flow regurgitation signal

  1 week after intervention

• Venous valve regurgitation or not

  Under the calf compression test, the venous valves were observed for blood flow regurgitation signal

  1 month after intervention

• Venous valve regurgitation or not

  Under the calf compression test, the venous valves were observed for blood flow regurgitation signal

  3 months after intervention

• Venous valve regurgitation or not

  Under the calf compression test, the venous valves were observed for blood flow regurgitation signal

  6 months after intervention

• Venous valve regurgitation or not

  Under the calf compression test, the venous valves were observed for blood flow regurgitation signal

  1 year after intervention

• Changes in the duration of venous valve regurgitation

  The duration of venous valve regurgitation was measured under calf compression test

  immediately after intervention

• Changes in the duration of venous valve regurgitation

  The duration of venous valve regurgitation was measured under calf compression test

  1 week after intervention

• Changes in the duration of venous valve regurgitation

  The duration of venous valve regurgitation was measured under calf compression test

  1 month after intervention

• Changes in the duration of venous valve regurgitation

  The duration of venous valve regurgitation was measured under calf compression test

  3 months after intervention

• Changes in the duration of venous valve regurgitation

  The duration of venous valve regurgitation was measured under calf compression test

  6 months after intervention

• Changes in the duration of venous valve regurgitation

  The duration of venous valve regurgitation was measured under calf compression test

  1 year after intervention

Study Arms (1)

Venous valve remodeling

EXPERIMENTAL

Venous valve function was remodeled under ultrasound guidance

Procedure: Ultrasound guided functional remodeling of lower extremity superficial vein valve

Interventions

Ultrasound guided functional remodeling of lower extremity superficial vein valve PROCEDURE

Preoperative ultrasound was used to re-evaluate and confirm the valve function, disinfect the tissue, inject hyaluronic acid around the great saphenous vein valve to reshape the valve about 1-2ml, monitor the whole process under ultrasound, pump back for protection during injection, and inject multiple times at different points.

Venous valve remodeling

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang Procince, 322000, China

RECRUITING

Related Publications (2)

• 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, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.

  PMID: 35027279 RESULT

• 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. J Int Med Res. 2021 May;49(5):3000605211014364. doi: 10.1177/03000605211014364.

  PMID: 33990156 RESULT

Study Officials

• Yuefeng Zhu, Master's

  The Fourth Affiliated Hospital Zhejiang University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Yuefeng Zhu, Master's

CONTACT

13868101010; zhuyuefeng@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A certain number of patients meeting the requirements (meeting the inclusion criteria, but not meeting the exclusion criteria) were selected for preoperative hemodynamic evaluation of lower extremity vein ultrasound to determine the reflux points and reflux points, identify the blood circulation pattern, and design an individualized surgical program. Intraoperative venous valve was reconstructed in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 22, 2023
• Study Start: April 19, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 30, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)