Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure

• Status: Completed
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical procedure, i.e. endovenous laser ablation of great saphenous vein, microphlebectomy of varicose branches. Two treatment groups (with and without additional pharmacotherapy) are compared.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Criteria

Inclusion Criteria:

• Men and women aged 18-65 years inclusive.

• Diagnosis: varicose veins of lower limbs in the GSV territory.

• Maximum diameter of target vein (GSV) - 15 mm.

• Clinical grade C4 according to CEAP classification.

• Absence of chronic diseases or acute diseases requiring first-line treatment.

Exclusion/withdrawal Criteria:

• Conditions that limit patient's adherence to study procedures (dementia, neuropsychological disorders, substance and alcohol dependence, etc.).

• Participation in other clinical trials (or administration of investigational medicinal products) within 3 months prior to the study.

• Patient's withdrawal from the study.

• History of thrombosis of superficial and/or deep veins of lower limbs at enrollment into the study.

• Current anticoagulant and phlebotropic therapy.

• Comorbidities requiring first-line treatment.