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A Feasibility Study of the ReLeaf Catheter System — ReLeaf  

Chronic Venous Insufficiency Clinical Trial

Official title:
A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein

Clinical Trial Summary

This study is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.

Clinical Trial Description

The ReLeaf catheter system is intended for the creation of tissue leaflets in the deep veins where existing valve structures are no longer healthy and effectively moving blood.

This study aims to treat subjects with a documented history of symptomatic chronic venous insufficiency in whom compression therapy for at least 6 months, combined with superficial venous and/or perforator surgery have failed to obtain clinical improvement.

This clinical trial is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02462096
Study type Interventional
Source Intervene, Inc.
Contact
Status Terminated
Phase N/A
Start date September 9, 2015
Completion date June 5, 2017
View Details
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