Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries
Teleflex
Summary
The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system
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 con…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years and ≤ 80 years of age 2. Subject has provided written informed consent as approved by the Ethics Committee / Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures 3. Subject is eligible for PCI according to the applicable guidelines 4. Subject is an acceptable candidate for coronary artery bypass surgery 5. Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patient…