The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study.

Overview

The purpose of this study is to learn whether the investigational device, the Hancock Jaffe bioprosthetic venous valve (VenoValve®) will help patients with severe CVI in their legs and whether the risks of being treated with the study valve are acceptable. The venous study valve is meant to make the problems that people with CVI have less severe, such as swelling, discoloration, pain, soreness, itchy or burning sensations, and ulcers on the leg.

The VenoValve is an artificial valve that is permanently implanted into a vein inside the leg to help blood that is pooling in the lower leg flow back to the heart.  This could help improve symptoms. Since the study valve is surgically implanted, removal of the study valve would require an additional surgical procedure.

Participants will be required to take Lovenox (enoxaparin) for 30 days following the implant procedure; at Day 30 the subject will be required to take the Direct Oral Anticoagulant (DOAC) Xarelto (rivaroxaban) for 12 months. Total study participation will last approximately 5 years.

Eligibility

  • Ages 18 and older
  • Diagnosis of severe chronic venous valvular insufficiency (CVI)
  • Additonal criteria must be met based on determination by Investigator and study requirements

Subjects will receive a $50 stipend in the form of an Advarra Card for the Day 7 and Month 3 Visits to compensate for gas and parking.

Description

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: chronic venous valvular insufficiency,CVI
  • Age: Between 18 Years - 100 Years
  • Gender: Male or Female
Updated on 20 Nov 2022 . Study ID: TX11537
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