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Clinical Trials/NCT04537052
NCT04537052
Unknown
Not Applicable

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

Kahramanmaras Sutcu Imam University0 sites24 target enrollmentSeptember 27, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Varicose Veins
Sponsor
Kahramanmaras Sutcu Imam University
Enrollment
24
Primary Endpoint
reflux times
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 27, 2020
End Date
January 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Responsible Party
Principal Investigator
Principal Investigator

Erdinç Eroğlu

Principal Investigator

Kahramanmaras Sutcu Imam University

Eligibility Criteria

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

Outcomes

Primary Outcomes

reflux times

Time Frame: 9 months

reduce reflux times

femoral vein diameters

Time Frame: 9 months

reduce femoral vein diameter

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