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

NCT ID: NCT04537052

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-27
• Study Completion Date: 2021-01-30

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.

Conditions

Primary Varicose Veins

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Onl Femoral vein

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

Group Type: EXPERIMENTAL

Ven Restoration Therapy

Intervention Type: PROCEDURE

This is a novel and promising method, applied percutaneously, in the treatment of deep venous insufficiency . In this method, developed based on the effects of compression garments, a polymer consisting of cyanoacrylate and hyaluronic acid is injected, with ultrasound-guidance, percutaneously around the femoral vein. In this way, the diameter of the vein is reduced, and function is restored to the inadequately functioning valve. The procedure is also called percutaneous valvuloplasty. The underlying idea in the development of this product was that hyaluronic acid might cause an increase in connective tissue, while cyanoacrylate could serve as an exoskeleton by forming heavy tissue.

Interventions

Ven Restoration Therapy

This is a novel and promising method, applied percutaneously, in the treatment of deep venous insufficiency . In this method, developed based on the effects of compression garments, a polymer consisting of cyanoacrylate and hyaluronic acid is injected, with ultrasound-guidance, percutaneously around the femoral vein. In this way, the diameter of the vein is reduced, and function is restored to the inadequately functioning valve. The procedure is also called percutaneous valvuloplasty. The underlying idea in the development of this product was that hyaluronic acid might cause an increase in connective tissue, while cyanoacrylate could serve as an exoskeleton by forming heavy tissue.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Erdinç Eroğlu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

11-2020/01

Identifier Type: -

Identifier Source: org_study_id