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

RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-01-15

Primary completion: 2022-02-15

Study completion finish: 2027-01-15

Study type

TREATMENT

Phase

Trial ID

NCT04253301

Intervention or treatment

DEVICE: InnoVein Valve Treatment

Conditions

• Chronic Venous Insufficiency

Image related to Chronic Venous Insufficiency

Condition: Chronic Venous Insufficiency
DEVICE: InnoVein Valve Treatment
Nedlands, Western Australia, Australia and more
Sponsor: InnoVein

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Sir Charles Gairdner Hospital

Research sites nearby

Select from list below to view details:

Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia
Flinders
Adelaide, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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

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

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency