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

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04253301
• Other study ID #: IM-CP-2001
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: January 15, 2027

Study information

• Verified date: September 2021
• Source: InnoVein
• Contact: InnoVen Data Management
• Phone: 650-302-0847
• Email: IM-CP-2001[@]innoveinmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: January 15, 2027
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Device:
• InnoVein Valve Treatment
Subjects will have the InnoVein Valve implanted

Locations

Country	Name	City	State
Australia	Flinders	Adelaide
Australia	Hollywood Private Hospital	Nedlands	Western Australia
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
InnoVein

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events	Number of Major Adverse Events	30 Days