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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2027
  • participants needed
    5
  • sponsor
    InnoVein
Updated on 25 February 2022
reflux

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.

Details
Condition Chronic Venous Insufficiency
Treatment InnoVein Valve Treatment
Clinical Study IdentifierNCT04253301
SponsorInnoVein
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note