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

Primary Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04537052
• Other study ID #: 11-2020/01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 27, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: September 2020
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Varicose Veins
• Varicose Veins
• Venous Insufficiency

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	femoral vein diameters	reduce femoral vein diameter	9 months
Primary	reflux times	reduce reflux times	9 months