The TARGET-IV NA Trial: Multicenter Randomized Assessment of the Firehawk® rapamycin TARGET eluting cobalt chromium coronary stent system - North American Trial

1) Age >= 18 years.
2) Patient understands the trial requirements and treatment procedures and
provides written informed consent prior to any trial-specific tests or treatment
3) 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
4) Patient is willing to comply with all protocol-required follow up
evaluations.
Angiographic Inclusion Criteria (visual estimate):
a. 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.
b. The coronary anatomy is deemed likely to allow delivery of a study device to
the target lesion(s).
c. 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,
Confidential and Proprietary bifurcation lesions (except planned dual stent
implantation), ostial lesions, tortuous lesions, and protected left main
lesions.
4) Overlapping stents are allowed

1) STEMI within 24 hours of initial time of presentation to the first treating
hospital, whether at a transfer facility or the study
hospital or in whom enzyme levels (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 <90 mm/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 or devices (e.g. cobalt chromium alloy, stainless
steel, sirolimus, everolimus and zotarolimus, or structurally related
compounds, polymer, all P2Y12 inhibitors, or aspirin).
8) Planned surgery within 6 months.
9) Subject has an indication for chronic oral anticoagulant treatment (with
either vitamin K antagonists or novel anticoagulants - NOACs)
10) Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation
(<40 mL/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 data interpretation.
18) Participation in another investigational drug or device trial that has not
yet reached its primary endpoint and that may interfere with protocol
compliance or confound data interpretation (as per the opinion of the
investigator); or intent to participate in another investigational drug or
device trial within 12 months.
19) Intention to become pregnant within 12 months (women of child-bearing
potential who are sexually active must agree to use contraceptives from the
time of enrollment through 12 months post procedure.
20) Pregnancy or nursing (women of child-bearing potential must have a
pregnancy test within 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
organ transplant.
23) Subject is receiving oral or intravenous immunosuppressive therapy or has
known life-limiting immunosuppressive or autoimmune disease (e.g., HIV).
Corticosteroids are 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

Note:
1. A maximum of 2 target vessels and up to 2 target lesions per vessel may be
treated. Lesions which are up to 10 mm apart and can be covered by a single
stent are considered one lesion.
2. Randomization will take place after the first target lesion has been crossed
with a wire and any lesion preparation (such as pre-dilation) has been
successfully achieved.
3. Lesions not meeting angiographic criteria may be treated as non-target
lesions but must meet the following conditions:
* Be located in non-target vessels
* Treated successfully prior to randomization, >24 hrs. prior to randomization
or if performed during the index procedure must be successful and uncomplicated
(<50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no
dissection >= NHLBI type C, no perforation, no persistent ST segment changes, no
prolonged chest pain, no TIMI major or BARC type 3 bleeding).
4. All target lesions are to be treated during baseline procedures and planned
staged procedures are not allowed. However, if during the procedure staging
becomes necessary (for example due to excessive contrast load) the staged
procedure should be completed within 6 weeks and should be performed with the
assigned (randomized) stent.