RecruitingNot ApplicableNCT04253301
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Sponsor
InnoVein
Enrollment
5 participants
Start Date
Jan 15, 2020
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria8
- 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
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Interventions
DEVICEInnoVein Valve Treatment
Subjects will have the InnoVein Valve implanted
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04253301
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