ID

20271

Description

The Intra-Drug Eluting Stent (DES) Restenosis Study; ODM derived from: https://clinicaltrials.gov/show/NCT00323895

Link

https://clinicaltrials.gov/show/NCT00323895

Keywords

Versions (1)
  1. 2/19/17 2/19/17 -
Uploaded on

February 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00323895

English

Eligibility Coronary Artery Disease NCT00323895

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii-iii) or patients with documented silent ischemia;
Description

Angina Pectoris Canadian Cardiovascular Society Grading Scale Class | Angina, Unstable | Silent myocardial ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1879987
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0340291
patient has an intra-des (taxus™ or cypher™) or intra-bms restenosis of >= 50% and <100% (by qca online of the mld compared to the distal reference diameter) in a native coronary artery;
Description

Restenosis Percent Drug-Eluting Stent Intra-arterial | Restenosis Percent Bare metal stent Intra-arterial | Quantitative Coronary Angiography | Minimum Vessel Lumen Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0333186
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1322815
UMLS CUI [1,4]
C0694634
UMLS CUI [2,1]
C0333186
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C2825200
UMLS CUI [2,4]
C0694634
UMLS CUI [3]
C4054139
UMLS CUI [4]
C3898305
study target lesion must be located in a restenotic native coronary artery >=2.25mm and <=3.5mm in lumen diameter and <=30mm in length by visual estimate and within a region up to 5mm to the proximal/distal stent edge;
Description

Target Lesion Identification Restenotic lesion of coronary artery | Target Lesion Lumen Diameter | Target Lesion Length

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1299362
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C3640173
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C1444754
study target lesion must have undergone coronary interventional treatment >= 4 weeks previously. patients with one ore more prior ptca procedures at the target lesion are acceptable candidates.
Description

Interventional procedure Coronary Target Lesion | Percutaneous Transluminal Coronary Angioplasty Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0205042
UMLS CUI [1,3]
C2986546
UMLS CUI [2,1]
C2936173
UMLS CUI [2,2]
C1265611
study target lesion can not be located in a vessel containing another lesion requiring treatment. lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, but they must be successfully treated prior to the treatment of the study target lesion;
Description

Target Lesion Identification Blood Vessel | Percutaneous Coronary Intervention Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0005847
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0221198
patient is candidate for a current percutaneous revascularisation technique;
Description

Indication Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1532338
patient is willing to comply with the specified follow-up evaluations (including angiographic follow-up);
Description

Compliance behavior Follow-up Evaluation | Compliance behavior Follow-up angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1261322
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C0002978
patient must provide written informed consent prior to the procedure using a form that is approved by the local ethics committee;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 72 hours and the ck enzymes remain above normal at the time of treatment;
Description

Q wave myocardial infarction | Non-Q wave myocardial infarction | Elevated creatine kinase | Creatine kinase (cardiac enzyme) level Elevated

Data type

boolean

Alias
UMLS CUI [1]
C0582803
UMLS CUI [2]
C0542269
UMLS CUI [3]
C0151576
UMLS CUI [4,1]
C3516327
UMLS CUI [4,2]
C3163633
has unstable angina classified as braunwald a i-ii-iii;
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
unprotected left main coronary disease with ³50% stenosis;
Description

Left main coronary artery disease | Stenosis Percentage

Data type

boolean

Alias
UMLS CUI [1]
C1299433
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
significant (>50%) stenoses of additional lesions proximal or distal to the target lesion(s) that might require revascularization or impede runoff;
Description

Lesion Additional | Stenosis Percentage | Target Lesion Proximal | Target Lesion Distal | Revascularization Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C0205107
UMLS CUI [4,1]
C2986546
UMLS CUI [4,2]
C0205108
UMLS CUI [5,1]
C0581603
UMLS CUI [5,2]
C0686904
target lesion is in an internal mammary artery, saphenous vein bypass graft or is located in the left main or is ostial;
Description

Target Lesion Identification | internal thoracic artery | saphenous vein bypass graft | Left coronary artery main stem | ostium of coronary artery

Data type

boolean

Alias
UMLS CUI [1]
C2986546
UMLS CUI [2]
C0226276
UMLS CUI [3]
C2067298
UMLS CUI [4]
C0226031
UMLS CUI [5]
C0226028
stent implantation(s) is a non-elective, emergency procedure;
Description

Placement of stent Emergency procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0522776
UMLS CUI [1,2]
C1298802
stent at the target restenosed lesion is neither taxus™ , cypher™ des nor a bms;
Description

Stent Target Lesion Restenosis | Drug-Eluting Stents | Bare metal stent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038257
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0333186
UMLS CUI [2]
C1322815
UMLS CUI [3]
C2825200
documented left ventricular ejection fraction <=25%;
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
totally occluded vessel (timi 0 level).
Description

Blood Vessel Occluded Total | Thrombolysis in Myocardial Infarction Flow Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0005847
UMLS CUI [1,2]
C1947917
UMLS CUI [1,3]
C0439810
UMLS CUI [2,1]
C3272266
UMLS CUI [2,2]
C0441800
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Similar models

Eligibility Coronary Artery Disease NCT00323895

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Angina Pectoris Canadian Cardiovascular Society Grading Scale Class | Angina, Unstable | Silent myocardial ischemia
Item
diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii-iii) or patients with documented silent ischemia;
boolean
C0002962 (UMLS CUI [1,1])
C1879987 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0340291 (UMLS CUI [3])
Restenosis Percent Drug-Eluting Stent Intra-arterial | Restenosis Percent Bare metal stent Intra-arterial | Quantitative Coronary Angiography | Minimum Vessel Lumen Diameter
Item
patient has an intra-des (taxus™ or cypher™) or intra-bms restenosis of >= 50% and <100% (by qca online of the mld compared to the distal reference diameter) in a native coronary artery;
boolean
C0333186 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1322815 (UMLS CUI [1,3])
C0694634 (UMLS CUI [1,4])
C0333186 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C2825200 (UMLS CUI [2,3])
C0694634 (UMLS CUI [2,4])
C4054139 (UMLS CUI [3])
C3898305 (UMLS CUI [4])
Target Lesion Identification Restenotic lesion of coronary artery | Target Lesion Lumen Diameter | Target Lesion Length
Item
study target lesion must be located in a restenotic native coronary artery >=2.25mm and <=3.5mm in lumen diameter and <=30mm in length by visual estimate and within a region up to 5mm to the proximal/distal stent edge;
boolean
C2986546 (UMLS CUI [1,1])
C1299362 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2,1])
C3640173 (UMLS CUI [2,2])
C2986546 (UMLS CUI [3,1])
C1444754 (UMLS CUI [3,2])
Interventional procedure Coronary Target Lesion | Percutaneous Transluminal Coronary Angioplasty Quantity
Item
study target lesion must have undergone coronary interventional treatment >= 4 weeks previously. patients with one ore more prior ptca procedures at the target lesion are acceptable candidates.
boolean
C0184661 (UMLS CUI [1,1])
C0205042 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C2936173 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Target Lesion Identification Blood Vessel | Percutaneous Coronary Intervention Lesion
Item
study target lesion can not be located in a vessel containing another lesion requiring treatment. lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, but they must be successfully treated prior to the treatment of the study target lesion;
boolean
C2986546 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1532338 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
Indication Percutaneous Coronary Intervention
Item
patient is candidate for a current percutaneous revascularisation technique;
boolean
C3146298 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Compliance behavior Follow-up Evaluation | Compliance behavior Follow-up angiography
Item
patient is willing to comply with the specified follow-up evaluations (including angiographic follow-up);
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0002978 (UMLS CUI [2,3])
Informed Consent
Item
patient must provide written informed consent prior to the procedure using a form that is approved by the local ethics committee;
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Q wave myocardial infarction | Non-Q wave myocardial infarction | Elevated creatine kinase | Creatine kinase (cardiac enzyme) level Elevated
Item
patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 72 hours and the ck enzymes remain above normal at the time of treatment;
boolean
C0582803 (UMLS CUI [1])
C0542269 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
C3516327 (UMLS CUI [4,1])
C3163633 (UMLS CUI [4,2])
Angina, Unstable
Item
has unstable angina classified as braunwald a i-ii-iii;
boolean
C0002965 (UMLS CUI [1])
Left main coronary artery disease | Stenosis Percentage
Item
unprotected left main coronary disease with ³50% stenosis;
boolean
C1299433 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Lesion Additional | Stenosis Percentage | Target Lesion Proximal | Target Lesion Distal | Revascularization Patient need for
Item
significant (>50%) stenoses of additional lesions proximal or distal to the target lesion(s) that might require revascularization or impede runoff;
boolean
C0221198 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C2986546 (UMLS CUI [3,1])
C0205107 (UMLS CUI [3,2])
C2986546 (UMLS CUI [4,1])
C0205108 (UMLS CUI [4,2])
C0581603 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
Target Lesion Identification | internal thoracic artery | saphenous vein bypass graft | Left coronary artery main stem | ostium of coronary artery
Item
target lesion is in an internal mammary artery, saphenous vein bypass graft or is located in the left main or is ostial;
boolean
C2986546 (UMLS CUI [1])
C0226276 (UMLS CUI [2])
C2067298 (UMLS CUI [3])
C0226031 (UMLS CUI [4])
C0226028 (UMLS CUI [5])
Placement of stent Emergency procedure
Item
stent implantation(s) is a non-elective, emergency procedure;
boolean
C0522776 (UMLS CUI [1,1])
C1298802 (UMLS CUI [1,2])
Stent Target Lesion Restenosis | Drug-Eluting Stents | Bare metal stent
Item
stent at the target restenosed lesion is neither taxus™ , cypher™ des nor a bms;
boolean
C0038257 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0333186 (UMLS CUI [1,3])
C1322815 (UMLS CUI [2])
C2825200 (UMLS CUI [3])
Left ventricular ejection fraction
Item
documented left ventricular ejection fraction <=25%;
boolean
C0428772 (UMLS CUI [1])
Blood Vessel Occluded Total | Thrombolysis in Myocardial Infarction Flow Grade
Item
totally occluded vessel (timi 0 level).
boolean
C0005847 (UMLS CUI [1,1])
C1947917 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
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