NCT02462096

A Feasibility Study of the ReLeaf Catheter System

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Intervene, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	ReLeaf	The ReLeaf catheter is expected to enable a physician to create tissue leaflets that, in turn, generate a valve effect in the deep veins of the legs.

Timeline

• Start date: 2015-09-09
• Primary completion: 2016-10-08
• Completion: 2017-06-05
• First posted: 2015-06-03
• Last updated: 2025-08-05

Locations

1 site across 1 country: New Zealand