Using 3D Imaging to Optimize Bifurcation Stenting

Study Overview
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Brief Summary
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The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation segment.

Detailed Description
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The recently developed optical frequency domain imaging (OFDI) can provide high quality resolution images of the coronary arteries. This new imaging system enhances the understanding of complex coronary lesions and the complex interaction between coronary devices and vessels by assembling/compiling 2-dimensional cross sections. This 3-dimensional reconstruction with strut segmentation becomes possible on-line in the TERUMO OFDI console with 3-dimensional imaging software, which enables stent enhancement and 3D reconstruction within one minute. This real time 3D OFDI will promote the utilisation of 3-dimensional assessment in the treatment of bifurcation lesions.

Official Title
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On-line 3-dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent: OPTIMUM Study

Conditions
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Coronary Artery Disease, Bifurcation Lesion

Intervention / Treatment
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* Device: 3D OFDI guidance arm
* Device: Angio guidance arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years of age and signed Informed Consent Subject has coronary artery disease involving a bifurcation with objective evidence of ischemia including patients with chronic stable angina, silent ischemia and non-ST segment elevation acute coronary syndrome (NSTE-ACS) Subject is appropriate to be treated by PCI according to the local practice (operator's judgment or heart team decision) Patients' residence is in the area covered by the hospital Patients with angiographically significant stenosis (>50 % by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in operator's opinion appropriate to be treated by PCI with a single stent strategy The size of main vessel matches available Ultimaster stent sizes (<4.0 mm, and 2.0 mm by visual assessment) The size of side branch is >2.0mm in diameter by visual assessment The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon Exclusion Criteria: Pregnancy Patients with ST elevation myocardial infarction Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material Known thrombocytopenia (platelet count< 100,000/mm3) Cardiogenic Shock Significant comorbidities precluding clinical follow-up (as judged by investigators) Major planned surgery that requires discontinuation of dual antiplatelet therapy History of stenting in the target bifurcation lesion Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in operator's opinion contrast injection during repeat OFDI pullback Severely tortuous or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal optical frequency domain imaging (OFDI) or excessive risk of complication to place an OFDI catheter Target lesion reference vessel diameter (RVD) < 2.25 and > 4 mm Other: Patient is judged inappropriate by the attending physician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D OFDI guidance arm<br>Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure | Device: 3D OFDI guidance arm<br>* Subjects randomized to 3D-guidance arm will undergo optical frequency domain imaging (OFDI) assessment in the main vessel after re-wiring into the jailed side branch following stent implantation. If the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm position in 2D and off-line 3D reconstruction. After procedure, OFDI is performed in the main branch.<br>|
| Active Comparator: Angio guidance arm<br>Bifurcation percutaneous coronary intervention (PCI) guided by angiography | Device: Angio guidance arm<br>* In angiography-guidance group, wire recrossing into the side branch will be performed using conventional fluoroscopic/angiographic guidance. After finishing the procedure, OFDI is performed in the main branch but the results will be blinded to the operators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of malapposed struts | Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel | at time of bifurcation PCI surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of fulfilling optimal recrossing criteria on 3D-OFDI | Measured as a percentage | at time of bifurcation PCI surgery | 
| Incomplete stent apposition (ISA) area (mm²) |  | at time of bifurcation PCI surgery | 
| Minimum lumen area (mm²) |  | at time of bifurcation PCI surgery | 
| Mean lumen area (mm²) |  | at time of bifurcation PCI surgery | 
| Minimum stent area (mm²) |  | at time of bifurcation PCI surgery | 
| Mean stent area (mm²) |  | at time of bifurcation PCI surgery | 
| Mean protrusion area (mm²) |  | at time of bifurcation PCI surgery | 
| Maximum protrusion area (mm²) |  | at time of bifurcation PCI surgery | 
| Minimum flow area (mm²) |  | at time of bifurcation PCI surgery | 
| Mean flow area (mm²) |  | at time of bifurcation PCI surgery |