Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
• Failed compression therapy of at least 6 months' duration;
• Deep system venous reflux characterized by \>1 second reflux time;
• Presence of at least one target site within the target vessel.
Locations
Other Locations
Australia
Royal Prince Alfred
RECRUITING
Camperdown
Prince of Wales
RECRUITING
Randwick
Canada
Vancouver Coastal Health Research Institute
RECRUITING
Vancouver
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Clinical Trials New Zealand Ltd
RECRUITING
Hamilton
Contact Information
Primary
Tracy Roberts
tracy@intervene-med.com
303-396-4603
Time Frame
Start Date: 2017-11-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 15
Treatments
Experimental: BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
Related Therapeutic Areas
Sponsors
Leads: Intervene, Inc.