Inclusion
Item
1. the target vessel must meet the following criteria:
boolean
C1512693 (UMLS CUI [1])
bifurcated lesion of a native coronary artery
Item
1. bifurcated lesion type 1, 2, 3 or 4 of a native coronary artery with a reference vessel diameter of 2.5 mm to 4.0 mm in the main branch and of ≥ 2.25 mm in the side branch.
boolean
C1299363 (UMLS CUI [1,1])
C1301408 (UMLS CUI [1,2])
Stenosis degree
Item
2. the target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
boolean
C0242231 (UMLS CUI [1,1])
C4034225 (UMLS CUI [1,2])
previously untreated
Item
3. the target lesion has not been previously treated with any interventional procedure.
boolean
C0332155 (UMLS CUI [1,1])
C1299363 (UMLS CUI [1,2])
Feasible for stent implantation
Item
4. the target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilatation with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
boolean
C0940860 (UMLS CUI [1])
C0002997 (UMLS CUI [2])
C1611184 (UMLS CUI [3])
C0009488 (UMLS CUI [4])
stable or unstable angina pectoris or a positive stress test for ischemia
Item
2. patient has stable or unstable angina pectoris (ccs classification i or greater) or a positive stress test for ischemia.
boolean
C0002962 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C0015260 (UMLS CUI [2,2])
Age, Pregnancy Test
Item
3. patient must be ≥ 18 years of age. 4. female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
boolean
C0001779 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
Other treatment, Informed Consent
Item
5. patient has no other treatment planned within 30 days of the procedure. 6. patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the ethics committee.
boolean
C0087111 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Patient compliance
Item
7. patient willing to comply with required post-procedure follow-up.
boolean
C1321605 (UMLS CUI [1])
Acute Myocardial Infarction
Item
1. patient has had an acute myocardial infarction (> 3x normal ck with presence of ckmb) within 72 hours preceding the index procedure and ck has not returned to normal limits at the time of the procedure.
boolean
C0155626 (UMLS CUI [1,1])
C0201973 (UMLS CUI [1,2])
hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity
Item
2. patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity that cannot be adequately pre-medicated.
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0038126 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0072980 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0009924 (UMLS CUI [6,2])
Platelet count, WBC count, liver disease
Item
3. patient has a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, a wbc of <3,000 cells/mm³, or documented or suspected liver disease.
boolean
C0005821 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
bleeding diathesis or coagulopathy, cva or tia, active peptic ulcer or upper gi bleeding, co-morbidity that may cause patient non-compliance, or is associated with limited life expectancy
Item
4. patient has a history of bleeding diathesis or coagulopathy. 5. patient has suffered a cva or tia within the past six months. 6. active peptic ulcer or upper gi bleeding within the prior 6 months. 7. patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years).
boolean
C0005779 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
C0041909 (UMLS CUI [5])
C1321605 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0009488 (UMLS CUI [6,3])
C0023671 (UMLS CUI [7])
Exclusion Criteria
Item
8. patient must be excluded from the study if any of these angiographic criteria are met:
boolean
C0680251 (UMLS CUI [1])
Thrombus
Item
1. the target vessel contains intraluminal thrombus.
boolean
C0087086 (UMLS CUI [1])
target lesion located in the left main coronary artery
Item
2. the target lesion is located in the left main coronary artery.
boolean
C0449685 (UMLS CUI [1,1])
C1261082 (UMLS CUI [1,2])
Calcification
Item
3. the target lesion or vessel shows angiographic evidence of severe calcification.
boolean
C1611184 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
previous PCI
Item
4. the patient has undergone previous pci to the target vessel within 6 months.
boolean
C1532338 (UMLS CUI [1])
Pre treatment of the lesion
Item
5. pre treatment of the lesion is done with a technique other than balloon angioplasty (e.g. rotablation).
boolean
C0087111 (UMLS CUI [1,1])
C3640041 (UMLS CUI [1,2])