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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 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
NA
Trial ID
NCT04253301
Intervention or treatment
DEVICE: InnoVein Valve Treatment
Conditions
- • Chronic Venous Insufficiency
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
| DEVICE: InnoVein Valve Treatment
|
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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