A staged prospective, randomized, non-blinded, multicenter study.
Persistent symptoms with at least 3 months of routine care including compression therapy, pneumatic compression, and in C6 patients, wound care with FDA approved medications or dressing solutions
Axial deep reflux >1 sec. in the femoral vein (above the P1 segment) and popliteal vein
Primary or Secondary deep venous valvular incompetence
CEAP score: C4b, C4c, C5, or C6
Known hypercoagulable condition including Factor V Leiden deficiency (homozygote), Prothrombin gene Mutation (homozygote), Antithrombin 3 deficiency, Protein C deficiency, Protein S deficiency and Antiphospholipid antibody
Any active cancer or cancer within 6 months of remission (excluding non-melanoma skin cancer)
Previous surgical procedure or endovascular procedure in the Target Vein Zone in the target extremity (ipsilateral leg)
Acute Deep Venous Thrombosis (DVT) or pulmonary embolism (PE) within 30 days of the procedure
Hancock Jaffe Laboratiores, Inc
Lead sponsor
NAMSA
Collaborator