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
Parallel
envve system
DeviceCatheter based valve system
Primary Safety Endpoint
The primary safety endpoint is the composite of all cause death and specified events that are adjudicated to be serious and related to the Device by the CEC measured at 30 days. Specified DRSAEs: * Pulmonary Embolism (PE) * enVVe Valve Embolization * enVVe Valve Infection * Target Vein Zone Thrombosis/DVT * Target Vein Zone perforation requiring endovascular or surgical intervention * Access Site Bleeding
Primary Effectiveness Endpoint
The primary effectiveness endpoint is the change in regurgitant (reflux) volume in the Target Vein Zone at 12 months, comparing the Treatment Arm and the Control Arm, as measured per Imaging Manual protocols and assessed by the core laboratory. For subjects in the Treatment Arm, regurgitant volume at 12 months will be measured through the enVVe Valve or, if imaging artifact or noise is present, at the nearest caudal location. For all study arms, only subjects demonstrating forward flow through the applicable imaged segment will be considered evaluable for the primary effectiveness endpoint.
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Hancock Jaffe Laboratiores, Inc
Lead sponsor
NAMSA
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
