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

Sponsor

Kahramanmaras Sutcu Imam University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04537052

Collaborator

(none)

Enrollment

Arm

4.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Varicose Veins	Procedure: Ven Restoration Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 27, 2020

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Jan 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Onl Femoral vein Ultrasound-guided controlled injection begins, and the venous diameter and gap between valves are reduced	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.

Arm

Intervention/Treatment

Experimental: Onl Femoral vein

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

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.

Outcome Measures

Primary Outcome Measures

femoral vein diameters [9 months]
reduce femoral vein diameter
reflux times [9 months]
reduce reflux times

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kahramanmaras Sutcu Imam University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erdinç Eroğlu, Principal Investigator, Kahramanmaras Sutcu Imam University

ClinicalTrials.gov Identifier:

NCT04537052

Other Study ID Numbers:

11-2020/01

First Posted:

Sep 3, 2020

Last Update Posted:

Sep 3, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erdinç Eroğlu, Principal Investigator, Kahramanmaras Sutcu Imam University

Deep venous insufficiency,

Additional relevant MeSH terms:

Venous Insufficiency

Varicose Veins

Study Results

No Results Posted as of Sep 3, 2020