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Scenario 1: Diagnostic No PCI Required

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1 Scenario 1: Diagnostic No PCI Required
Left Coronary Artery (LCA) Right Coronary Artery (RCA) LCX 50mm RCA 65mm GC GC LAD 70mm Study Segment Qualifications: At least one Suspected Index Culprit Lesion (LAD) At least two major epicardial vessels eligible for IVUS-NIRS Imaging (RCA , LAD, LCX) At least 50mm total pullback (Visually estimated LAD 70mm pullback, LCX 50 mm pullback, RCA 65mm. Approximate total 185mm pullback of scanned coronary artery) Total Eligible Length (excludes stents & borders) = ~185mm Suspected Index Culprit Lesion: Prox LAD Unblinded Run: LAD Index Non-Culprit Artery: RCA, LCX Blinded Run(s): LCX, RCA PCI Performed: No PCI performed = Suspected Index Culprit Lesion = Blinded Scan = Guide Catheter = Unblinded Scan = 5mm excluded stent border = Treated Segment; scanned but not included in analysis XXXXX= Stent

2 Scenario 2: Single Lesion PCI
GC LCA RCA LAD 45mm GC LCX 60mm RCA 50mm Total Eligible Length (excluding stent & borders) = ~155mm Suspected Index Culprit Lesion: RCA Unblinded Run: RCA Index Non-Culprit Artery: LAD, LCX Blinded Run(s): LCX, LAD PCI Performed On: Prox RCA XXXXX GC Study Segment Qualifications: At least one Suspected Index Culprit Lesion (RCA) At least two major epicardial vessels eligible for IVUS-NIRS Imaging (RCA , LAD, LCX) At least 50mm total pullback (Visually estimated LAD 45mm pullback, LCX 60 mm pullback, RCA 50mm. Approximate total 155mm pullback of scanned coronary artery) Exclude 5mm borders = Suspected Index Culprit Lesion = Blinded Scan = Guide Catheter = Unblinded Scan = 5mm excluded stent border = Treated Segment; scanned but not included in analysis XXXXX = Stent RCA 50mm

3 Scenario 3: Chronic Total Occlusion
RCA GC LCA RCA GC CTO LAD 35mm LCX 55mm RCA GC Study Segment Qualifications: At least one Suspected Index Culprit Lesion (RCA) At least two major epicardial vessels eligible for IVUS-NIRS Imaging (LAD, LCX) At least 50mm total pullback (Visually estimated LAD 35mm pullback, LCX 55 mm pullback. Approximate total 90mm pullback of scanned coronary artery) Total Eligible Legth (exluding stents & borders) = ~90mm Suspected Index Culprit Lesion: RCA Unblinded Run: RCA Index Non-Culprit Artery: LAD, LCX Blinded Run(s): LCX, LAD PCI Performed On: Prox RCA RCA GC =Suspected Index Culprit Lesion = Blinded Scan XXXXXXXXXXX = Guide Catheter = Unblinded Scan Exclude 5mm borders = Treated Segment; scanned but not included in analysis = 5mm excluded stent border XXXXX = Stent

4 Scenario 4: Ramus Present
LCA RCA LAD 45mm GC GC RCA 70mm LCX 55mm Ramus 20mm Study Segment Qualification: At least one Suspected Index Culprit Lesion (LCX) At least two major epicardial vessels eligible for IVUS-NIRS Imaging (RCA , LAD, LCX, Ramus) At least 50mm total pullback (Visually estimated LAD 45mm pullback, LCX 55 mm pullback, RCA 70mm, Ramus 20mm. Approximate total 190mm pullback of scanned coronary artery) Total Eligible Length (excluding stent & borders)= ~190mm Suspected Index Culprit Lesion: Prox LCX Unblinded Run: LCX Index Non-Culprit Artery: LAD, RCA, Ramus Blinded Run: LAD, RCA, Ramus PCI Performed On: No PCI performed = Suspected Index Culprit Lesion = Blinded Scan = Guide Catheter = Unblinded Scan = 5mm excluded stent border = Treated Segment; scanned but not included in analysis XXXXX = Stent

5 Scenario 5: Multi Lesion PCI
LCA RCA GC GC Total Eligible Lengh (excluding stent & borders)= ~75mm Suspected Index Culprit Lesion: LAD, RCA Unblinded Run: LAD, RCA Index Non-Culprit Artery: Prox RCA Blinded Run: N/A PCI Performed On: Prox RCA and Prox/Mid LAD LAD 25mm RCA 50mm = Suspected Index Culprit Lesion Exclude 5mm borders Study Segment Qualifications: At least one Suspected Index Culprit Lesion (LAD, RCA) At least two major epicardial vessels eligible for IVUS-NIRS Imaging (RCA , LAD) At least 50mm total pullback (Visually estimated LAD 25mm pullback, RCA 50mm. Approximate total 75mm pullback of scanned coronary artery) Exclude 5mm borders = Unblinded Scan XXXXXX = Treated Segment; scanned but not included in analysis GC XXXXX LAD 25mm = Blinded Scan GC = Guide Catheter XXXXXX = 5mm excluded stent border RCA 50mm XXXXX = Stent

6 Scenario 6: Prior Stenting
LCA RCA XXX GC GC LAD 35mm XXXXXXXXXXXXX Exclude 5mm borders RCA 15mm LCX 40mm Study Segment Qualifications: At least one Suspected Index Culprit Lesion (LAD, RCA) At least two major epicardial vessels eligible for IVUS-NIRS Imaging (RCA , LAD, LCX) At least 50mm total pullback (Visually estimated LAD 35mm pullback, RCA 15mm, LCX 40mm. Approximate total 90mm pullback of scanned coronary artery) Total Eligible Length (exluding stent & borders) = ~90mm Suspected Index Culprit Lesion: LAD, RCA Unblinded Run: LAD, RCA Index Non-Culprit Artery: LCX Blinded Run: LCX PCI Performed On: No PCI = Suspected Index Culprit Lesion = Blinded Scan = Guide Catheter = Unblinded Scan = 5mm excluded stent border = Treated Segment; scanned but not included in analysis XXXXX = Stent

7 Scenario 7: Single Lesion PCI and Ramus
LCA RCA LAD Ramus 35mm RCA 80mm LCX 40mm LCX Total Eligible Length (excluding stent & borders)= ~180mm Suspected Index Culprit Lesion: LAD Unblinded Run: LAD Index Non-Culprit Artery: LCX, RCA, Ramus Blinded Run: LCX, RCA, Ramus PCI Performed On: Prox LAD Exclude 5mm borders LAD 25mm Study Segment Qualifications: At least one Suspected Index Culprit Lesion (LAD) At least two major epicardial vessels eligible for IVUS-NIRS Imaging (RCA , LAC, LCX) At least 50mm total pullback (Visually estimated LAD 25mm pullback, LCX 40 mm pullback, RCA 80mm, Ramus 35mm. Approximate total 180mm pullback of scanned coronary artery) XXXXX = Suspected Index Culprit Lesion = Blinded Scan Ramus 35mm = Guide Catheter = Unblinded Scan = 5mm excluded stent border LCX 40mm = Treated Segment; scanned but not included in analysis XXXXX= Stent


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