ID

35529

Beschrijving

EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III); ODM derived from: https://clinicaltrials.gov/show/NCT02027870

Link

https://clinicaltrials.gov/show/NCT02027870

Trefwoorden

Versies (1)
  1. 07-03-19 07-03-19 -
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See clinicaltrials.gov

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7 maart 2019

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02027870

Engels

Eligibility Coronary Artery Disease NCT02027870

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1.18yrs≤age≤75yrs . 2..stability and unstable angina pectoris (ap), chronic myocardial infarction (omi) or confirmed (myocardial ischemia; 3.de novo lesion at native coronary artery(up to four target lesions). 4.lesion length ≤60mm. 5.rvd 2.25mm～4.0mm. 6.ds%≥70% by visual estimation. 7.coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.subjects are willing to follow the specified requirements follow-up.
Beschrijving

Age | Stable angina | Angina, Unstable | Chronic myocardial infarction | Myocardial Ischemia | Lesion de novo Coronary artery Native | Target Lesion Quantity | Lesion Length | Reference Vessel Diameter | Percent Diameter Stenosis Measurement | Coronary Artery Bypass Surgery | Adherence Clinical Study Follow-up

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4]
C1392608
UMLS CUI [5]
C0151744
UMLS CUI [6,1]
C0221198
UMLS CUI [6,2]
C1515568
UMLS CUI [6,3]
C0205042
UMLS CUI [6,4]
C0302891
UMLS CUI [7,1]
C2986546
UMLS CUI [7,2]
C1265611
UMLS CUI [8,1]
C0221198
UMLS CUI [8,2]
C1444754
UMLS CUI [9,1]
C1706462
UMLS CUI [9,2]
C0005847
UMLS CUI [9,3]
C1301886
UMLS CUI [10]
C3897965
UMLS CUI [11]
C0010055
UMLS CUI [12,1]
C1510802
UMLS CUI [12,2]
C3274571
9.to understand the purpose of testing, voluntary and signed informed consent, willing to accept the imaging and clinical follow-up of subjects.
Beschrijving

Comprehension Testing | Informed Consent | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0039593
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. ami within 7 days.
Beschrijving

Acute myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0155626
2. left main lesion, transplant vasculopathy and stent restenosis lesion;
Beschrijving

Left coronary artery main stem Lesion | Transplant Vasculopathy | Stent restenosis Lesion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0226031
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C0042373
UMLS CUI [3,1]
C3272317
UMLS CUI [3,2]
C0221198
3. severe calcified lesion unable to predilate.
Beschrijving

Lesion Calcified Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205082
4. the distortion of the stent was hampered by lesions.
Beschrijving

Stent Distortion Interfered by Lesion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710193
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0221198
5. nyha≥ⅲ or lvef＜35%.
Beschrijving

New York Heart Association Classification | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0428772
6. prior stenting within 1 year.
Beschrijving

Stenting Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348535
UMLS CUI [1,2]
C0205156
7. pregnancy or lactation, and plan in postoperative pregnancy or lactation.
Beschrijving

Pregnancy | Breast Feeding | Planned Pregnancy Postoperative | Breast Feeding Postoperative Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0032790
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0032790
UMLS CUI [4,3]
C1301732
8. subjects had bleeding tendency or blood coagulation dysfunction or pci contraindications, or anticoagulant therapy taboo or can't continue dapt healers at least 1 year.
Beschrijving

Bleeding tendency | Blood Coagulation Disorders | Medical contraindication PCI | Anticoagulant therapy Taboo | Dual Antiplatelet therapy Continue Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1532338
UMLS CUI [4,1]
C0150457
UMLS CUI [4,2]
C0039227
UMLS CUI [5,1]
C1096021
UMLS CUI [5,2]
C0205173
UMLS CUI [5,3]
C0549178
UMLS CUI [5,4]
C1272705
9. there are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
Beschrijving

Malignant Neoplasms | Congestive heart failure | Organ Transplantation | Organ Transplantation Anticipated | Substance Use Disorders | Poor compliance | Interference Explanation Research data | Life Expectancy Limited

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0029216
UMLS CUI [4,1]
C0029216
UMLS CUI [4,2]
C3840775
UMLS CUI [5]
C0038586
UMLS CUI [6]
C0032646
UMLS CUI [7,1]
C0521102
UMLS CUI [7,2]
C0681841
UMLS CUI [7,3]
C0681873
UMLS CUI [8,1]
C0023671
UMLS CUI [8,2]
C0439801
10. to aspirin heparin clopidogrel cobalt chromium alloy rapamycin pla polymer contrast agent of one of allergy.
Beschrijving

Aspirin allergy | Heparin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Cobalt-Chromium Alloys | Hypersensitivity Sirolimus | Hypersensitivity Polylactic acid Polymer | Contrast media allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2]
C0571776
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0008576
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0072980
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0071443
UMLS CUI [6,3]
C0032521
UMLS CUI [7]
C0570562
11. serious liver and kidney function is not complete person(alt and ast were three times greater than the upper limit of normal).
Beschrijving

Liver function Serious | Renal function Serious | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
12. rounding out the top participated in other clinical trials have not reached the main research the finish time limit.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
13. the researchers determine adherence is poor, could not finish my study in accordance with the requirements of the subjects.
Beschrijving

Poor compliance | Completion of clinical trial failed

Datatype

boolean

Alias
UMLS CUI [1]
C0032646
UMLS CUI [2,1]
C2732579
UMLS CUI [2,2]
C0231175
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Similar models

Eligibility Coronary Artery Disease NCT02027870

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Stable angina | Angina, Unstable | Chronic myocardial infarction | Myocardial Ischemia | Lesion de novo Coronary artery Native | Target Lesion Quantity | Lesion Length | Reference Vessel Diameter | Percent Diameter Stenosis Measurement | Coronary Artery Bypass Surgery | Adherence Clinical Study Follow-up
Item
1.18yrs≤age≤75yrs . 2..stability and unstable angina pectoris (ap), chronic myocardial infarction (omi) or confirmed (myocardial ischemia; 3.de novo lesion at native coronary artery(up to four target lesions). 4.lesion length ≤60mm. 5.rvd 2.25mm～4.0mm. 6.ds%≥70% by visual estimation. 7.coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.subjects are willing to follow the specified requirements follow-up.
boolean
C0001779 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C1392608 (UMLS CUI [4])
C0151744 (UMLS CUI [5])
C0221198 (UMLS CUI [6,1])
C1515568 (UMLS CUI [6,2])
C0205042 (UMLS CUI [6,3])
C0302891 (UMLS CUI [6,4])
C2986546 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0221198 (UMLS CUI [8,1])
C1444754 (UMLS CUI [8,2])
C1706462 (UMLS CUI [9,1])
C0005847 (UMLS CUI [9,2])
C1301886 (UMLS CUI [9,3])
C3897965 (UMLS CUI [10])
C0010055 (UMLS CUI [11])
C1510802 (UMLS CUI [12,1])
C3274571 (UMLS CUI [12,2])
Comprehension Testing | Informed Consent | Protocol Compliance
Item
9.to understand the purpose of testing, voluntary and signed informed consent, willing to accept the imaging and clinical follow-up of subjects.
boolean
C0162340 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Acute myocardial infarction
Item
1. ami within 7 days.
boolean
C0155626 (UMLS CUI [1])
Left coronary artery main stem Lesion | Transplant Vasculopathy | Stent restenosis Lesion
Item
2. left main lesion, transplant vasculopathy and stent restenosis lesion;
boolean
C0226031 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0040732 (UMLS CUI [2,1])
C0042373 (UMLS CUI [2,2])
C3272317 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
Lesion Calcified Severe
Item
3. severe calcified lesion unable to predilate.
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Stent Distortion Interfered by Lesion
Item
4. the distortion of the stent was hampered by lesions.
boolean
C1710193 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
New York Heart Association Classification | Left ventricular ejection fraction
Item
5. nyha≥ⅲ or lvef＜35%.
boolean
C1275491 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Stenting Previous
Item
6. prior stenting within 1 year.
boolean
C2348535 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Planned Pregnancy Postoperative | Breast Feeding Postoperative Planned
Item
7. pregnancy or lactation, and plan in postoperative pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0032790 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Bleeding tendency | Blood Coagulation Disorders | Medical contraindication PCI | Anticoagulant therapy Taboo | Dual Antiplatelet therapy Continue Unsuccessful
Item
8. subjects had bleeding tendency or blood coagulation dysfunction or pci contraindications, or anticoagulant therapy taboo or can't continue dapt healers at least 1 year.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C1532338 (UMLS CUI [3,2])
C0150457 (UMLS CUI [4,1])
C0039227 (UMLS CUI [4,2])
C1096021 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C0549178 (UMLS CUI [5,3])
C1272705 (UMLS CUI [5,4])
Malignant Neoplasms | Congestive heart failure | Organ Transplantation | Organ Transplantation Anticipated | Substance Use Disorders | Poor compliance | Interference Explanation Research data | Life Expectancy Limited
Item
9. there are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
boolean
C0006826 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0029216 (UMLS CUI [3])
C0029216 (UMLS CUI [4,1])
C3840775 (UMLS CUI [4,2])
C0038586 (UMLS CUI [5])
C0032646 (UMLS CUI [6])
C0521102 (UMLS CUI [7,1])
C0681841 (UMLS CUI [7,2])
C0681873 (UMLS CUI [7,3])
C0023671 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
Aspirin allergy | Heparin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Cobalt-Chromium Alloys | Hypersensitivity Sirolimus | Hypersensitivity Polylactic acid Polymer | Contrast media allergy
Item
10. to aspirin heparin clopidogrel cobalt chromium alloy rapamycin pla polymer contrast agent of one of allergy.
boolean
C0004058 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0008576 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0072980 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0071443 (UMLS CUI [6,2])
C0032521 (UMLS CUI [6,3])
C0570562 (UMLS CUI [7])
Liver function Serious | Renal function Serious | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
11. serious liver and kidney function is not complete person(alt and ast were three times greater than the upper limit of normal).
boolean
C0232741 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Study Subject Participation Status
Item
12. rounding out the top participated in other clinical trials have not reached the main research the finish time limit.
boolean
C2348568 (UMLS CUI [1])
Poor compliance | Completion of clinical trial failed
Item
13. the researchers determine adherence is poor, could not finish my study in accordance with the requirements of the subjects.
boolean
C0032646 (UMLS CUI [1])
C2732579 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
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