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

Not Applicable

Completed

• Conditions: Subjects undergoing PCI for: -Angina (stable or unstable) -Silent ischemia (at least one of the following must be present: a visually estimated target lesion diameter stenosis of ?70%, a positive non-invasive stress test, or FFR ?0.80)-NSTEMI-Recent STEMI (>24 hours from initial presentation and stable)

• Registration Number: JPRN-jRCT1090220211
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

General Inclusion Criteria:
1) Age greater than or equal to 18 years
2) Patient with an indication for PCI including:
- Angina (stable or unstable),
- Silent ischemia (a visually estimated target lesion diameter stenosis of greater than or equal to 70%, a positive non-invasive stress test, or FFR less than or equal to 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 greater than or equal to 2.25 mm to less than or equal to 3.50 mm.
2) Lesion length <40mm
Note: Overlapping stents are allowed

Exclusion Criteria

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

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, TIMI Grade 3 flow, no dissection ? NHLBI type C, no perforation, no prolonged chest pain or ST segment elevation or depression (>30 minutes), no peri-procedural MI as measured by CKMB >5x 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 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint (powered). Post-PCI MSA assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Testing will be done in a hierarchal manner as follows:<br>1. Non-inferiority of OCT guided stenting to IVUS guided stenting<br>2. Superiority of OCT guided stenting to Angiography guided stenting<br>3. Superiority of OCT guided stenting to IVUS guided stenting<br>Primary Safety Endpoint (non-powered). Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, or pericardiocentesis).