The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study
Diseases of the Cardiovascular System
What is the purpose of this trial?
A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).
The purpose of this study is to evaluate the VenoValve System (Hancock Jaffe Laboratories) in human patients. The VenoValve System is designed for treatment of chronic deep venous insufficiency. The VenoValve System enables improvement in chronic lower extremity venous reflux through an open surgical technique. The objective of this study is to assess the safety and effectiveness of the VenoValve System for the treatment of patients with deep venous valvular insufficiency and the associated complications.
- Ages18 years and older
- Trial withHancock Jaffe Laboratories Inc.
- Start Date10/20/2021
- End Date05/31/2022
- Last Updated01/11/2022
- Study HIC#2000030794