OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation

ILUMIEN III: OPTIMIZE PCI: OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in Percutaneous Coronary Intervention (PCI)

The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation

This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.

Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group 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 FFR ≤0.80 must be present),
   • NSTEMI, or
   • Recent 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

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 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 LVEF <30%.
13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
14. Cerebrovascular accident 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
2. Left main diameter stenosis ≥30% or left main PCI planned.
3. Study target lesion in a bypass graft
4. Ostial 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)