Actively Recruiting
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Led by InnoVein · Updated on 2021-09-17
5
Participants Needed
3
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.
CONDITIONS
Official Title
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 greater than 1 year
- Reflux time greater than 1 second in the superficial femoral and/or popliteal vein
You will not qualify if you...
- Any prior deep vein intervention within 6 months prior to the Index Procedure
- History of 2 or more deep vein thromboses (DVTs)
- Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or inferior vena cava (IVC)
- Current placement of an inferior vena cava (IVC) filter
- 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 before 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
2
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
3
Flinders
Adelaide, Australia
Actively Recruiting
Research Team
I
InnoVen Data Management
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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