Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

Inclusion Criteria:

1. Age ≥ 18 years.

2. Patient understands the trial requirements and treatment procedures and provideswritten informed consent prior to any trial-specific tests or treatment.

3. Patients with an indication for PCI including angina (stable or unstable), silentischemia (in absence of symptoms a visually estimated target lesion diameterstenosis of ≥70%, a positive non-invasive stress test, or a positive coronaryphysiology 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 STEMIthe time of presentation to the first treating hospital, whether a transfer facilityor 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.

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

Angiographic inclusion criteria:

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

2. The coronary anatomy is deemed likely to allow delivery of a study device to thetarget lesion(s).

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

4. Overlapping stents are allowed

Exclusion Criteria:

1. STEMI within 24 hours of initial time of presentation to the first treatinghospital, whether at a transfer facility or the study hospital or in whom enzymelevels (either CK-MB or Troponin) have not peaked.

2. PCI within the 24 hours preceding the baseline procedure.

3. History of stent thrombosis.

4. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support,including IABP.

5. Subject is intubated.

6. Known LVEF <30%.

7. Subject has a known allergy to contrast (that cannot be adequately pre-medicated)and/or the trial stent system or any protocol-required concomitant medications ordevices (e.g. cobalt chromium alloy, stainless steel, sirolimus, everolimus orstructurally related compounds, polymer, any P2Y12 inhibitor, or aspirin).

8. Planned surgery within 6 months.

9. Subject has an indication for chronic oral anticoagulant treatment (with eithervitamin K antagonists or novel anticoagulants - NOACs)

10. Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation (<40mL/min for subjects participating in the angiographic follow-up sub-study).

11. Hemoglobin <10 g/dL.

12. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3.

13. White blood cell (WBC) count <3,000 cells/mm3.

14. Clinically significant liver disease.

15. Active peptic ulcer or active bleeding from any site.

16. Other serious medical illness with a life-expectancy < 24 months (e.g. cancer,severe heart failure, severe lung disease).

17. A planned procedure that may cause non-compliance with the protocol or confound datainterpretation.

18. Participation in another investigational drug or device trial that has not yetreached its primary endpoint and that may interfere with protocol compliance orconfound data interpretation (as per the opinion of the investigator); or intent toparticipate in another investigational drug or device trial within 12 months.

19. Intention to become pregnant within 12 months (women of child-bearing potential whoare sexually active must agree to use contraceptives from the time of enrollmentthrough 12 months post-procedure).

20. Pregnancy or nursing (women of child-bearing potential must have a pregnancy testwithin 7 days prior to the index procedure).

21. Any co-morbid condition that may cause non-compliance with the protocol (e.g.dementia, substance abuse, etc.).

22. Subject has received an organ transplant or is on a waiting list for an organtransplant.

23. Subject is receiving oral or intravenous immunosuppressive therapy or has knownlife-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroidsare allowed.

Angiographic Exclusion Criteria:

1. Unprotected left main interventions

2. Bifurcation lesions with intended dual stent implantations

3. DES restenotic lesions

4. Prior PCI in the target vessel in the 12 months prior to enrollment

5. Any lesion in the target vessel that is likely to require PCI within 12 months

6. Stent lengths >36mm for diameters 2.0 mm and 2.25 mm (i.e., very long thin stents).

7. Lesion with intended ≥ 3 stent implantation