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

Not Applicable

Recruiting

• Conditions: Chronic Venous Insufficiency
• Interventions: Device: InnoVein Valve Treatment

• Registration Number: NCT04253301
• Lead Sponsor: InnoVein

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-17
• Primary Completion: 2022-02-15
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	InnoVein Valve Treatment	Subjects will have the InnoVein Valve implanted

Primary Outcome Measures

Name	Time	Method
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events	30 Days	Number of Major Adverse Events

Trial Locations

Locations (3)

Flinders; 🇦🇺 Adelaide, Australia

Hollywood Private Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia