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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: InnoVein Valve Treatment

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 Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: InnoVen Data Management; Phone Number: 650-302-0847; Email: IM-CP-2001@innoveinmedical.com

Study Locations

• Australia
  • Adelaide, Australia
    • Recruiting
    • Flinders
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Sir Charles Gairdner Hospital
      • Contact: Shirley Jansen, MD; Phone Number: +61 8 6151 0820; Email: JShirley.Jansen@health.wa.gov.au
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Hollywood Private Hospital
      • Contact: Krys Hiscock, RN; Phone Number: 0474 769 593; Email: nursing@affinityresearch.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects will have the InnoVein Valve implanted	Device: InnoVein Valve Treatment; Subjects will have the InnoVein Valve implanted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events	Number of Major Adverse Events	30 Days

Collaborators and Investigators

• Sponsor: InnoVein

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Anticipated): February 15, 2022
• Study Completion (Anticipated): January 15, 2027

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: IM-CP-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No