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

Primary Purpose

Chronic Venous Insufficiency

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

InnoVein Valve Treatment

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hollywood Private HospitalRecruiting
Sir Charles Gairdner HospitalRecruiting
FlindersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Subjects will have the InnoVein Valve implanted

Outcomes

Primary Outcome Measures

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

Number of Major Adverse Events

Secondary Outcome Measures

Full Information

NCT ID

NCT04253301

First Posted

January 31, 2020

Last Updated

September 15, 2021

Sponsor

InnoVein

1. Study Identification

Unique Protocol Identification Number

NCT04253301

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2020 (Actual)

Primary Completion Date

February 15, 2022 (Anticipated)

Study Completion Date

January 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InnoVein

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Venous Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Subjects will have the InnoVein Valve implanted

Intervention Type

Device

Intervention Name(s)

InnoVein Valve Treatment

Intervention Description

Subjects will have the InnoVein Valve implanted

Primary Outcome Measure Information:

Title

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

Description

Number of Major Adverse Events

Time Frame

30 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

InnoVen Data Management

Phone

650-302-0847

IM-CP-2001@innoveinmedical.com

Facility Information:

Facility Name

Hollywood Private Hospital

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krys Hiscock, RN

Phone

0474 769 593

nursing@affinityresearch.com.au

Facility Name

Sir Charles Gairdner Hospital

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shirley Jansen, MD

Phone

+61 8 6151 0820

JShirley.Jansen@health.wa.gov.au

Facility Name

Flinders

City

Adelaide

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melanie Toomey

Phone

08 82045445

Melanie.Toomey@sa.gov.au

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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