Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial

• Age ≥ 18 years.

• Patient understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment.

• Patients with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or a positive coronary physiology test (e.g. FFR≤0.80 or iFR\<0.90 or rFR ≤ 0.89 must be present), NSTEMI, or recent STEMI (STEMI \>24 hours and in whom enzyme levels have peaked). For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.

• Patient is willing to comply with all protocol-required follow-up evaluations.

⁃ Angiographic inclusion criteria:

• Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.25 mm to ≤4.0 mm and up to 44 mm in length.

• The coronary anatomy is deemed likely to allow delivery of a study device to the target lesion(s).

• Complex lesions are allowed including calcified lesions (lesion preparation is allowed and strongly recommended with current approved devices (e.g. scoring/cutting balloon and rotational/orbital atherectomy), multivessel disease, CTO,bifurcation lesions (except planned dual stent implantation), ostial lesions, tortuous lesions, and protected left main lesions.

• Overlapping stents are allowed