Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
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- STATUS
- Recruiting
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- End date
- Jan 15, 2026
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- participants needed
- 5
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- sponsor
- InnoVein
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 |
|---|---|
| Age | 18-100 years |
| Treatment | InnoVein Valve Treatment |
| Clinical Study Identifier | NCT04253301 |
| Sponsor | InnoVein |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
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