Age
Item
1. subject must be at least 18 -75 years of age
boolean
C0001779 (UMLS CUI [1])
Study Subject Eligible Percutaneous Coronary Intervention
Item
2. subject is eligible for percutaneous coronary intervention (pci)
boolean
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
Target Lesion Location Coronary artery | Reference Vessel Diameter
Item
3. target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (rvd) ≥2.25 mm and ≤4.0 mm, length must be ≤34*
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
Target Lesion Stenosis Percentage | Thrombolysis in Myocardial Infarction Flow
Item
mm (by visual estimate), target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in myocardial infarction (timi) flow >1
boolean
C2986546 (UMLS CUI [1,1])
C1261287 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Percutaneous Coronary Intervention Planned | Surgery staged operation Included | Coronary Artery Bypass Surgery Planned
Item
1. planned pci (including staged procedures) or cabg after the index procedure
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C4027584 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Complete Blood Count Out of range
Item
2. subject with out of range complete blood count (cbc) values that are determined by the study physician to be clinically significant.
boolean
C0009555 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
Dialysis | Creatinine measurement, serum
Item
3. subject is on dialysis or has baseline serum creatinine level >2.0 mg/dl (177µmol/l)
boolean
C0011946 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Therapeutic procedure Planned | Lesion Quantity | Lesion Blood Vessel Epicardial Quantity | Lesion Single Stent Quantity
Item
4. planned treatment of more than 3 lesions, planned treatment of lesions in more than 2 major epicardial vessels, planned treatment of a single lesion with more than 1 stent
boolean
C0087111 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0005847 (UMLS CUI [3,2])
C0442016 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C0221198 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0038257 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Target Lesion Location Left anterior descending coronary artery | Target Lesion Location Left circumflex coronary artery
Item
5. target lesion(s) is located within 3 mm of the origin of the left anterior descending (lad) coronary artery or left circumflex (lcx) coronary artery by visual estimate.
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0226032 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0226037 (UMLS CUI [2,3])
Target Lesion Dissection
Item
6. target vessel develops a dissection greater than national heart, lung, blood institute (nhlbi) type c following the pre-dilatation/pre-treatment of the first target lesion
boolean
C2986546 (UMLS CUI [1,1])
C0012737 (UMLS CUI [1,2])