Summary
This study is testing 2 devices for blocked arteries. One is a new magnesium device that helps your artery heal and then slowly dissolves in about one year. Your body replaces it with natural materials. The other is a regular metal stent that stays in your body forever. Doctors want to learn which one is safer and works better.
Description
The BIOMAG-III clinical trial is a prospective, international, multi-center, single-blinded, randomized controlled, non-inferiority trial to compare the Freesolve Sirolimus Eluting Coronary Resorbable Magnesium Scaffold (Freesolve RMS) System with the Xience Everolimus Eluting Stent (Xience DES) System. with respect to Target Lesion Failure (TLF) rate at 12 months. Subjects will be randomized in a 2:1 fashion Freesolve to Xience. A total of up to 1859 subjects will be randomized at up to 120 total sites worldwide including North America, Europe, and Asia Pacific. Clinical follow-up will be conducted at 1, 6, and 12 months and at 2, 3, 4, and 5 years post-procedure.
Principal Investigator
Study Coordinator
Faculty Contact
Research Contact
CAMC Clinical Trials Center - 304-388-9944