Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Flinders
RECRUITING
Adelaide
Hollywood Private Hospital
RECRUITING
Nedlands
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Contact Information
Primary
InnoVen Data Management
IM-CP-2001@innoveinmedical.com
650-302-0847
Time Frame
Start Date: 2020-01-15
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 5
Treatments
Experimental: Treatment
Subjects will have the InnoVein Valve implanted
Related Therapeutic Areas
Sponsors
Leads: InnoVein