A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT)

Kahramanmaraş Sütçü İmam University (KSU)

Status: Unknown

Conditions: Primary Varicose Veins

Treatments: Procedure: Ven Restoration Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04537052

11-2020/01

Details and patient eligibility

About

To present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Before the procedure, junctional femoral vein diameters and reflux times were measured. CEAP classification and Venous clinical severity scores (VCSS) were recorded. Chronic Venous Insufficiency Questionnaire (CIVIQ-20) were also recorded. Then, VRT was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. After the procedure, vein diameters and reflux times were measured again. All parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency,
• volunteering to take part in the study were included

Exclusion criteria

• post-thrombotic or congenital deep venous insufficiency
• Venous reflux disease in the GSV diagnosed by clinical symptoms
• Local or systemic infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Onl Femoral vein

Experimental group

Description:

Ultrasound-guided controlled injection begins, and the venous diameter and gap between valves are reduced

Treatment:

Procedure: Ven Restoration Therapy