Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: InnoVein Valve Treatment.
- Who it may be relevant to
- Registry conditions: Chronic Venous Insufficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device InnoVein Valve Treatment
Subjects will have the InnoVein Valve implanted
Primary outcome measures
- Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events [Time frame: 30 Days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Hollywood Private Hospital — Nedlands
- Sir Charles Gairdner Hospital — Nedlands
- Flinders — Adelaide
Identifiers
NCT: NCT04253301 · IM-CP-2001