Age
Item
1. the patient must be ≥18 and ≤ 80 years of age
boolean
C0001779 (UMLS CUI [1])
Myocardial Ischemia Symptomatic
Item
2. symptomatic ischemic heart disease;
boolean
C0151744 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient Acceptable Coronary Artery Bypass Surgery | Patient Acceptable Angioplasty
Item
3. acceptable candidate for coronary artery bypass graft (cabg) or angioplasty;
boolean
C0030705 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0162577 (UMLS CUI [2,3])
Target Lesion Location Coronary artery Native
Item
4. target lesion located in a native coronary artery
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
Target Lesion Length Maximum | Target Lesion covered by Balloon Single
Item
5. target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon;
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1555028 (UMLS CUI [2,2])
C0441144 (UMLS CUI [2,3])
C0205171 (UMLS CUI [2,4])
Reference Vessel Diameter
Item
6. reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate;
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Target Lesion Stenosed Percentage
Item
7. target lesion ≥50% and <100% stenosed by visual estimate
boolean
C2986546 (UMLS CUI [1,1])
C0333181 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Restenosis | Vessel Main Stented
Item
8. restenosis of initially stented main vessel.
boolean
C0333186 (UMLS CUI [1])
C0005847 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C0038257 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
1. pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Acute myocardial infarction
Item
2. patient has had a known diagnosis of acute myocardial infarction (ami) within 72 hours preceding the index procedure;
boolean
C0155626 (UMLS CUI [1])
Lesion Bypass graft | Bifurcation lesion
Item
3. lesions in bypass grafts or bifurcations
boolean
C0221198 (UMLS CUI [1,1])
C0185098 (UMLS CUI [1,2])
C1299363 (UMLS CUI [2])
Treatment intended Vessel | Exception Target vessel | Treatment intended Lesion | Left coronary artery main stem | Ostium Lesion | Chronic total occlusion | Vessel Calcified | Bifurcation | Graft Venous | Thrombus Angiography | Atherectomy | Thrombectomy | Pre treatment | Exception Balloon Angioplasty
Item
4. any non-target vessel or lesion intended to be treated during the index procedure, which is an unprotected left main, ostial lesion, chronic total occlusion (cto), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
boolean
C0087111 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0449618 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0221198 (UMLS CUI [3,3])
C0226031 (UMLS CUI [4])
C0444567 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
C1955779 (UMLS CUI [6])
C0005847 (UMLS CUI [7,1])
C0175895 (UMLS CUI [7,2])
C3146289 (UMLS CUI [8])
C0332835 (UMLS CUI [9,1])
C0348013 (UMLS CUI [9,2])
C0087086 (UMLS CUI [10,1])
C0002978 (UMLS CUI [10,2])
C0162513 (UMLS CUI [11])
C0162578 (UMLS CUI [12])
C2709094 (UMLS CUI [13])
C1705847 (UMLS CUI [14,1])
C0002996 (UMLS CUI [14,2])
Shock, Cardiogenic
Item
5. patient presents with cardiogenic shock;
boolean
C0036980 (UMLS CUI [1])
Peripheral Vascular Disease Extensive | Secure sheath insertion excluded
Item
6. patient has extensive peripheral vascular disease that precludes safe 6 french sheath insertion
boolean
C0085096 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0463345 (UMLS CUI [2,1])
C0441587 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Left main coronary artery disease | Stenosis Percentage
Item
7. unprotected left main coronary artery disease with ≥50% stenosis;
boolean
C1299433 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Target vessel Occluded Total | TIMI Flow
Item
8. totally occluded target vessel (timi flow 0);
boolean
C0449618 (UMLS CUI [1,1])
C1947917 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2])
Target Lesion Calcified | Dilate procedure Unsuccessful
Item
9. calcified target lesion(s) which cannot be successfully pre-dilated;
boolean
C2986546 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C1322279 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Stenosis Percentage Proximal Target Lesion | Stenosis Percentage Distal Target Lesion | Coverage Balloon Unsuccessful
Item
10. a significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon
boolean
C1261287 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0205107 (UMLS CUI [1,3])
C2986546 (UMLS CUI [1,4])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0205108 (UMLS CUI [2,3])
C2986546 (UMLS CUI [2,4])
C1999244 (UMLS CUI [3,1])
C0441144 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Diffuse disease Distal Target Lesion | Blood flow Impaired
Item
11. diffuse distal disease to target lesion with impaired runoff;
boolean
C1299384 (UMLS CUI [1,1])
C0205108 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0232338 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
12. left ventricular ejection fraction (lvef) ≤30% (lvef must be obtained within 1 months prior to the index procedure).
boolean
C0428772 (UMLS CUI [1])