Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

InnoVein5 enrolled

Overview

This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.

Chronic Venous Insufficiency occurs when the venous wall and/or valves in the leg veins are not working effectively, making it difficult for blood to return to the heart from the legs.The core etiology of the disease stems from increased venous pressure and incompetent venous valves leading to regurgitation of blood that accumulates in the legs. It has been shown that implantation or recreation of a functional valve can lead to clearance of excess blood and resolution of symptoms. The InnoVein Valve and Delivery System is a new, investigational biocompatible valve intended to support natural flow in vessels in patients with Chronic Venous Insufficiency. The purpose of this study is to assess the safety of the InnoVein Valve and Delivery System for treatment of Chronic Venous Insufficiency.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Venous Insufficiency

Interventions

InnoVein Valve TreatmentDEVICE

Subjects will have the InnoVein Valve implanted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Willing and able to provide written Informed Consent * Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein * Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication * Life expectancy \>1yr * Reflux time \>1s in the superficial femoral and/or popliteal vein Key Exclusion Criteria: * Any prior deep vein intervention within 6 months prior to the Index Procedure * History of 2+ DVTs * Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC * Current IVC Placement * History of pulmonary embolism within 6 months * Conditions that increase the risk of device thrombosis or patient bleeding * Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure * Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol

Locations (3)

Hollywood Private Hospital

Nedlands, Western Australia, Australia

RECRUITING

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

RECRUITING

Flinders

Adelaide, Australia

RECRUITING

Outcomes

Primary Outcomes

Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events

Number of Major Adverse Events

Time frame: 30 Days

Central Contacts

InnoVen Data Management

CONTACT

650-302-0847 IM-CP-2001@innoveinmedical.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.