BioFreedom US IDE Feasibility Trial

This is a multi-center prospective trial of 100 patients at up to 10 centers. The study
population will consist of patients preventing with symptomatic ischemic heart disease due
to de novo stenotic lesion(s) in native coronary artery(ies) with reference vessel diameter
between 2.25 mm and 4.0 mm.

The primary safety endpoint for this clinical trial is the occurrence of major adverse
cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction,
target lesion revascularization and academic research consortium (ARC) definite stent
thrombosis within 9 months following the implantation.

The primary effectiveness endpoint for this trial is in-stent late lumen loss at 9 months as
compared to historical control

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