Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
ConditionChronic Venous Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnoVein
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
InnoVein Valve Treatment
DeviceSubjects will have the InnoVein Valve implanted
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of the InnoVein Valve and Delivery System: Number of Major Adverse Events
Number of Major Adverse Events
Time frame
30 Days Source ClinicalTrials.gov