ILUMIEN III: OPTIMIZE PCI

This is a prospective, post market, international, multi-center, randomized trial.

Patients undergoing coronary angiography with possibility of PCI will be consented to
participate in the study. Patients who provide informed consent and who meet all eligibility
criteria will be randomized 1:1:1 to undergo PCI with either OCT, IVUS, or Angiography
guidance.

All patients will undergo baseline and post PCI imaging with their randomized modality. In
addition, the Angiography and IVUS groups will undergo a blinded post-PCI OCT run to allow
comparison of OCT derived minimum stent area (MSA) in both groups.

After hospital discharge, all patients will have clinical follow-up at 30 days and 1 year.

General Inclusion Criteria:

1. Age ≥ 18 years.

2. Patient with an indication for PCI including:

- Angina (stable or unstable),

- Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a
positive non-invasive stress test, or fractional flow reserve (FFR) ≤0.80 must be
present),

- Non-ST segment elevation myocardial infarction (NSTEMI), or

- Recent ST segment elevation myocardial infarction (STEMI) (>24 hours from initial
presentation and stable).

3. Patients will undergo cardiac catheterization and possible or definite PCI with intent
to stent using any non-investigational metallic drug-eluting stent (DES)

4. Signed written informed consent

Angiographic inclusion criteria:

1. The target lesion must be located in a native coronary artery with visually estimated
reference vessel diameter of ≥2.25 mm to ≤3.50 mm.

2. Lesion length <40mm Note: Overlapping stents are allowed

General Exclusion Criteria:

1. Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the
patient is on dialysis

2. STEMI within 24 hours of initial time of presentation to the first treating hospital,
whether at a transfer facility or the study hospital.

3. PCI within 24 hours preceding the study procedure.

4. PCI of a lesion within the target vessel within 12 months prior to the study procedure

5. Planned use of bare metal stent (BMS)

6. Planned use of bioresorbable vascular scaffold (BVS)

7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90
mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support,
including Intra-aortic balloon pump (IABP), at time of procedure.

8. Mobitz II second degree or complete heart block

9. Malignant ventricular arrhythmias requiring treatment

10. Pulmonary edema defined as patient with shortness of breath, evidence of volume
overload on physical exam, and crepitations on physical exam (>1/3 of lungs) or
radiographic interstitial or alveolar pulmonary edema

11. Subject is intubated.

12. Known left ventricular ejection fraction (LVEF) <30%.

13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)

14. Cerebrovascular accident ( CVA) or transient ischemic attack within the past 6 months,
or any permanent neurologic defect attributed to CVA.

15. Presence of one or more co-morbidities which reduces life expectancy to less than 12
months or may interfere with protocol study processes.

16. Known allergy to protocol-required concomitant medications including aspirin;
clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast
that cannot be adequately pre-medicated.

17. Patient is participating in any other investigational drug or device clinical trial
that has not reached its primary endpoint.

18. Women who are pregnant or breastfeeding (women of child-bearing potential must have a
negative pregnancy test within one week before treatment).

Angiographic Exclusion Criteria:

1. The presence of any non-study lesion in the target vessel with angiographic diameter
stenosis >50%, or any additional target vessel stenosis which requires PCI either
during or within 12 months after the study procedure

Note: Patients may have non-study lesions in a non-target vessel that require PCI.
These lesions must be treated prior to randomization, with the procedure being
successful and uncomplicated. Alternatively non-study lesions in a non-target vessel
may be treated >24 hours prior to or >48 hours after the study procedure.

Successful and uncomplicated procedure is defined as <30% visually estimated residual
diameter stenosis, Thrombolysis In Myocardial Infarction (TIMI) Grade 3 flow, no
dissection ≥ National Heart, Lung and Blood Institute (NHLBI) type C, no perforation,
no prolonged chest pain or ST segment elevation or depression (>30 minutes), no
peri-procedural myocardial infarction (MI) as measured by creatine kinase-MB (CKMB)
>5x upper limits of normal (ULN) or troponin >35x ULN.

2. Left main diameter stenosis ≥30% or left main PCI planned.

3. Study target lesion in a bypass graft

4. Ostial right coronary artery (RCA) study target lesion

5. Chronic total occlusion (TIMI flow 0/1) study target lesion

6. Bifurcation study lesion with a planned dual stent strategy

7. In-stent restenosis study target lesion

8. Any study lesion characteristic resulting in the expected inability to deliver the
IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel
calcification or tortuosity)