This clinical trial is for men and women diagnosed with ischemic heart disease (myocardial ischemia) who are eligible to be treated with coronary angioplasty (PCI). Eligible patients include persons with angina (stable, unstable, or post-infarct), or silent ischemia.
The purpose of the study is to evaluate the safety and effectiveness of the Absorb Bioresorbable Vascular Scaffold (BVS) System made by Abbott Vascular. Unlike traditional metal stents which remain in the body permanently, the Absorb BVS dissolves into the blood vessel, leaving behind a treated vessel that is free of a permanent metallic implant.
Study subjects will be randomized to receive either the Absorb BVS or a commercially approved stent, and will be followed up for 5 years.
Men and women age 18 and older who are diagnosed with myocardial ischemia(e.g., silent ischemia, angina, myocardial infarction), who are suitable for elective PCI, may enroll in this study. and must have one or two new lesions in the coronary arteries. After enrollment, additional imaging may be required to confirm eligibility.
Detailed eligibility requirements will be reviewed when you contact the study team.
Dolores Reynolds, R.N., phone 212-746-4617, email firstname.lastname@example.org
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions. ClinicalTrials.gov Identifier NCT02173379