Age
Item
1. males or females, aged >18 years.
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease | Intervention Coronary Scheduled | Bare metal coronary stent placement | Coronary Restenosis de novo | Coronary Restenosis First
Item
2. patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery.
boolean
C1956346 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1522318 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C2609297 (UMLS CUI [3])
C0948480 (UMLS CUI [4,1])
C1515568 (UMLS CUI [4,2])
C0948480 (UMLS CUI [5,1])
C0205435 (UMLS CUI [5,2])
Target Lesion Coronary Vessel size
Item
3. target lesion must be in a native coronary vessel of 2.25 – 4.0 mm size.
boolean
C2986546 (UMLS CUI [1,1])
C0010075 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Target Lesion Length
Item
4. target lesion has to be of less than or equal to 25 mm length.
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Lesion Double
Item
5. tandem lesion may be included as long as:
boolean
C0221198 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Lesion Double Length
Item
overall length is less than or equal to 25 mm
boolean
C0221198 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
Lesion Double Therapeutic procedure Stent Single
Item
tandem lesion will be treated with one stent and counted as one lesion.
boolean
C0221198 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0038257 (UMLS CUI [1,4])
C0205171 (UMLS CUI [1,5])
Exclusion Criteria Occurrence Timepoint
Item
the following exclusion criteria must not be present at baseline visit 1 (bl1, screening visit prior to coronary intervention). if an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.
boolean
C0680251 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Target Lesion Reference Vessel size
Item
1. target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.
boolean
C2986546 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1706462 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Target Lesion Obstruction Total | Target Lesion Location Coronary Vessel Bifurcation
Item
2. target lesion is a total occlusion or located at a bifurcation.
boolean
C2986546 (UMLS CUI [1,1])
C0028778 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
C3640041 (UMLS CUI [2,3])
Lesion Therapeutic procedure Stent Quantity
Item
3. treatment affords implantation of more than one stent per treated lesion.
boolean
C0221198 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Brachytherapy Target Lesion
Item
4. target lesion was already treated by brachytherapy.
boolean
C0006098 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Target Lesion criteria
Item
5. target lesion has one or more of the following criteria:
boolean
C2986546 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Left coronary artery main stem Lesion
Item
left main lesion
boolean
C0226031 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Ostium of right coronary artery Lesion
Item
ostial lesion of the rca
boolean
C0226045 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Target Lesion Location Anterior descending branch of left coronary artery | Target Lesion Location circumflex branch of left coronary artery
Item
located at less than 2 mm after the origin of the lad or rcx.
boolean
C2986546 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0226032 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
C0226037 (UMLS CUI [2,3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])