This clinical trial is for men and women diagnosed with coronary artery disease who qualify for stenting of coronary artery lesions.
The purpose of the study is to evaluate the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System made by Biotronik. This is a thin, flexible stent that is coated with a material that inhibits inflammation and cell proliferation, which may reduce adverse reactions compared to other metal stents.
Study subjects will be followed up for up to 5 years after placement of the stent.
Men and women age 18 and older who have coronary artery disease, who are acceptable candidates for percutaneous coronary intervention (PCI, commonly known as angioplasty), with documented evidence of ischemic heart disease, stable or unstable angina pectoris, or silent ischemia, may enroll.
Enrolled subjects will receive standard medical tests to detect lesions in a major coronary artery. If none is detected, they will exit the study and receive appropriate therapy.
Detailed eligibility requirements will be reviewed when you contact the study team.
Dolores Reynolds, R.N., phone 212-746-4617, email dtr2001@med.cornell.edu
BIOFLOW-V: BIOTRONIK – A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with up to Three De Novo or Restenotic Coronary Artery Lesions – V. ClinicalTrials.gov Identifier NCT02389946