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

Not Applicable

• Conditions: Primary Varicose Veins
• Interventions: Procedure: Ven Restoration Therapy

• Registration Number: NCT04537052
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-01
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-03
• Last Update Posted: 2020-09-03
• Study Start: 2020-09-27
• Primary Completion: 2020-12-30
• Study Completion: 2021-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Onl Femoral vein	Ven Restoration Therapy	Ultrasound-guided controlled injection begins, and the venous diameter and gap between valves are reduced

Primary Outcome Measures

Name	Time	Method
reflux times	9 months	reduce reflux times
femoral vein diameters	9 months	reduce femoral vein diameter