Clinical trial NCT05914740: Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
Official title: Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins of Lower Limb
Keywords: Varicose veins in the lower extremities
Ultrasonic guidance
venous valve of Lower limb
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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 remodeled in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area.

Screening period (before surgery 14 days to 0 days) Subject signs informed consent. General information and previous medical history of subjects were collected, preoperative laboratory examination (blood routine, blood biochemistry, coagulation function, preoperative immunity, blood type), electrocardiogram, ultrasound, preoperative hemodynamic evaluation of lower extremity vein were completed, and evaluation scales such as CEAP grading, VCSS, AVVQ, CIVIQ and pain score were completed.

Subjects who meet the inclusion criteria and do not meet all exclusion criteria will be admitted.

Day of surgery (day 0) Preoperative ultrasound was re-evaluated to confirm the valve function, and the tissue was disinfected. Hyaluronic acid was injected around the valve of the great saphenous vein to rebuild the valve about 1-2ml, and the whole process was monitored under ultrasound. During the injection, the valve function was pumped back for protection, and the injection was performed multiple times at different points. Supplementary injection: Following the subject's voluntary principle, the researcher can give supplementary injection after evaluating the general condition of the subject.

The follow-up period for each subject was 12 months ±20 days after enrollment. Follow-up period (±3 days at 1 week, ±5 days at 1 month, ±10 days at 3 months, ±15 days at 6 months, ±20 days at 1 year) General data of subjects were collected, laboratory examination (blood routine and blood biochemistry) and postoperative ultrasound hemodynamic evaluation of lower limb veins were improved, and evaluation scales such as VCSS, AVVQ, CIVIQ and pain score were completed.

This study does not involve vulnerable groups.

Eligibility criteria: 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

Primary outcomes:
measure: Venous valve regurgitation or not
timeFrame: immediately after intervention
measure: Venous valve regurgitation or not
timeFrame: 1 week after intervention
measure: Venous valve regurgitation or not
timeFrame: 1 month after intervention
measure: Venous valve regurgitation or not
timeFrame: 3 months after intervention
measure: Venous valve regurgitation or not
timeFrame: 6 months after intervention
measure: Venous valve regurgitation or not
timeFrame: 1 year after intervention
measure: Changes in the duration of venous valve regurgitation
timeFrame: immediately after intervention
measure: Changes in the duration of venous valve regurgitation
timeFrame: 1 week after intervention
measure: Changes in the duration of venous valve regurgitation
timeFrame: 1 month after intervention
measure: Changes in the duration of venous valve regurgitation
timeFrame: 3 months after intervention
measure: Changes in the duration of venous valve regurgitation
timeFrame: 6 months after intervention
measure: Changes in the duration of venous valve regurgitation
timeFrame: 1 year after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang Procince
Study officials:
affiliation: The Fourth Affiliated Hospital Zhejiang University School of Medicine
name: Yuefeng Zhu, Master's
role: STUDY_DIRECTOR
References:
citation: 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.
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. J Int Med Res. 2021 May;49(5):3000605211014364. doi: 10.1177/03000605211014364.