BioFreedom US IDE Feasibility Trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring ischemic heart disease, CAD Read More

Inclusion Criteria:

• Individual is ≥ 18 years of age
• Individual must have clinical evidence if ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
• Individual must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
• Individual is competent and willing to provide informed consent to participate in the trial

Exclusion Criteria:

• A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or a sensitivity to contrast media that cannot be adequately pre-medicated;
• History or known allergic reaction or significant sensitivity to drugs similar to BA9;
• A platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, or a WBC < 3,000 cells/mm3;
• A creatinine level > 2.5 mg/dL;
• Evidence of an acute myocardial infarction with 72 hours of the intended stenting (defined as: Q wave or non-Q wave myocardial infarction having a Troponin either I or T pre-procedure elevated above the Institution's upper limit of normal);
• Previous or planned PCI of any vessel within 30 days pre or post procedure;
• Patient unable to take clopidogrel for 3 months or patient who have comorbidities that would prohibit the cessation of clopidogrel at 3 months;
• Planned adjunctive treatment during the intended stenting (eg balloon valvuloplasty, percutaneous endovascular intervention, etc)
• During the intended or index procedure the target lesion(s) requires treatment with a device other than a plain old balloon prior to stent placement (such as, but not limited to, cutting balloon, directional atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc);
• History of documented prior stroke within 6 months of the intended procedure;
• Active peptic ulcer or upper gastrointestinal bleeding documented within the prior 6 months;
• History of active bleeding diathesis or coagulopathy or will refuse blood transfusion;
• Individual is pregnant, nursing or planning to be pregnant;
• Any previous or planned treatment of the target vessel(s) with anti-restenotic therapies including, but not limited to brachytherapy;
• Concurrent medical condition with a life expectancy of less than 12 months or individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study;
• Individual is currently enrolled in another investigational drug or device trial. If, however, if investigational trial device or drug becomes commercially available, these trials are not considered investigational;
• Previous ACS within 9 months of pre or post procedure