ID

28754

Beschreibung

ProStent Coronary Drug-Eluting Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00887211

Link

https://clinicaltrials.gov/show/NCT00887211

Stichworte

Versionen (1)
  1. 01.02.18 01.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. Februar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00887211

Englisch

Eligibility Coronary Disease NCT00887211

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18-75 years, men or unpregnant women;
Beschreibung

Age | Gender | Pregnancy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
2. angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
Beschreibung

Angina Pectoris | Myocardial Ischemia Asymptomatic | Myocardial Infarction obsolete

Datentyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C0231221
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0521120
3. total of lesion artery ≤2;
Beschreibung

Lesion Artery Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0003842
UMLS CUI [1,3]
C1265611
4. lesion artery ≤30 mm in length, 2.5 to 4.0 mm in diameter (ocular estimate);
Beschreibung

Lesion Artery Length Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0003842
UMLS CUI [1,3]
C1444754
UMLS CUI [1,4]
C1301886
5. narrow level of lesion artery ≥70% in diameter (ocular estimate);
Beschreibung

Lesion Artery Percentage Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0003842
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C1301886
6. amount of same stents implanted in a lesion artery ≤2;
Beschreibung

Placement of stent Quantity Lesion Artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522776
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0221198
UMLS CUI [1,4]
C0003842
7. patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
Beschreibung

Indication Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0010055
8. patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept fellow-up
Beschreibung

Informed Consent | Follow-up Willing

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with acute myocardial infarction in recent one month;
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
2. chronic total occlusion lesions(timi 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.5mm;
Beschreibung

Chronic Total Occlusion Lesion | TIMI Flow Grade | Trunk of left coronary artery Lesion | Lesion Branch Quantity Treatment required for | Coronary Vessel Bifurcation Lesion | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3275069
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C3272266
UMLS CUI [2,2]
C4263591
UMLS CUI [3,1]
C0920980
UMLS CUI [3,2]
C0221198
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1253959
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0332121
UMLS CUI [5]
C3640041
UMLS CUI [6]
C3846158
3. severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
Beschreibung

Lesion Calcific Severe | Lesion Twisted | Lesion Inappropriate Stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0231467
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0038257
4. in-stent restenosis lesions;
Beschreibung

In Stent restenosis Lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3272317
UMLS CUI [1,2]
C0221198
5. patients with stent implantation in his/her coronary artery within recent one year;
Beschreibung

Placement of stent in coronary artery

Datentyp

boolean

Alias
UMLS CUI [1]
C0521232
6. severs heart failure(over nyha iii grade ), or left ventricular ejection fraction(lvef)< 40%( supersonic inspection or left ventricular radiography );
Beschreibung

Heart failure Severe New York Heart Association Classification | Left ventricular ejection fraction Left ventricle Radiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0225897
UMLS CUI [2,3]
C0034571
7. kidney functional damage prior to implantation, serum creatinine level＞2.0mg/dl;
Beschreibung

Kidney function impaired prior to Implantation | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184571
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0021107
UMLS CUI [2]
C0201976
8. patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
Beschreibung

Bleeding tendency | Digestive ulcer | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Cerebral apoplexy | Medical contraindication Platelet Inhibitors | Medical contraindication Anticoagulants | Patients Inappropriate Anticoagulation Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0237938
UMLS CUI [3]
C2937358
UMLS CUI [4]
C0038525
UMLS CUI [5]
C0038454
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0032188
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0003280
UMLS CUI [8,1]
C0030705
UMLS CUI [8,2]
C1548788
UMLS CUI [8,3]
C0003281
9. patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
Beschreibung

Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Heparin allergy | Contrast media allergy | Hypersensitivity Rapamycin | Metal allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0040207
UMLS CUI [4]
C0571776
UMLS CUI [5]
C0570562
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0072980
UMLS CUI [7]
C0577627
10. patients whose life expectancy less than 12 months;
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
11. patients who are participating in other drugs or medical devices clinical trials;
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
12. patients who can not comply with the clinical trial protocol;
Beschreibung

Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
13. patients having a heart transplant.
Beschreibung

Heart Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0018823
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Ähnliche Modelle

Eligibility Coronary Disease NCT00887211

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender | Pregnancy Absent
Item
1. age 18-75 years, men or unpregnant women;
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Angina Pectoris | Myocardial Ischemia Asymptomatic | Myocardial Infarction obsolete
Item
2. angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
boolean
C0002962 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3,1])
C0521120 (UMLS CUI [3,2])
Lesion Artery Quantity
Item
3. total of lesion artery ≤2;
boolean
C0221198 (UMLS CUI [1,1])
C0003842 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Lesion Artery Length Diameter
Item
4. lesion artery ≤30 mm in length, 2.5 to 4.0 mm in diameter (ocular estimate);
boolean
C0221198 (UMLS CUI [1,1])
C0003842 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
Lesion Artery Percentage Diameter
Item
5. narrow level of lesion artery ≥70% in diameter (ocular estimate);
boolean
C0221198 (UMLS CUI [1,1])
C0003842 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
Placement of stent Quantity Lesion Artery
Item
6. amount of same stents implanted in a lesion artery ≤2;
boolean
C0522776 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0003842 (UMLS CUI [1,4])
Indication Coronary Artery Bypass Surgery
Item
7. patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Informed Consent | Follow-up Willing
Item
8. patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept fellow-up
boolean
C0021430 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
1. patients with acute myocardial infarction in recent one month;
boolean
C0027051 (UMLS CUI [1])
Chronic Total Occlusion Lesion | TIMI Flow Grade | Trunk of left coronary artery Lesion | Lesion Branch Quantity Treatment required for | Coronary Vessel Bifurcation Lesion | Other Coding
Item
2. chronic total occlusion lesions(timi 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.5mm;
boolean
C3275069 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C3272266 (UMLS CUI [2,1])
C4263591 (UMLS CUI [2,2])
C0920980 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C1253959 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332121 (UMLS CUI [4,4])
C3640041 (UMLS CUI [5])
C3846158 (UMLS CUI [6])
Lesion Calcific Severe | Lesion Twisted | Lesion Inappropriate Stent
Item
3. severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0231467 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0038257 (UMLS CUI [3,3])
In Stent restenosis Lesion
Item
4. in-stent restenosis lesions;
boolean
C3272317 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Placement of stent in coronary artery
Item
5. patients with stent implantation in his/her coronary artery within recent one year;
boolean
C0521232 (UMLS CUI [1])
Heart failure Severe New York Heart Association Classification | Left ventricular ejection fraction Left ventricle Radiography
Item
6. severs heart failure(over nyha iii grade ), or left ventricular ejection fraction(lvef)< 40%( supersonic inspection or left ventricular radiography );
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2,1])
C0225897 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
Kidney function impaired prior to Implantation | Creatinine measurement, serum
Item
7. kidney functional damage prior to implantation, serum creatinine level＞2.0mg/dl;
boolean
C0184571 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
C0201976 (UMLS CUI [2])
Bleeding tendency | Digestive ulcer | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Cerebral apoplexy | Medical contraindication Platelet Inhibitors | Medical contraindication Anticoagulants | Patients Inappropriate Anticoagulation Therapy
Item
8. patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
boolean
C1458140 (UMLS CUI [1])
C0237938 (UMLS CUI [2])
C2937358 (UMLS CUI [3])
C0038525 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0032188 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0003280 (UMLS CUI [7,2])
C0030705 (UMLS CUI [8,1])
C1548788 (UMLS CUI [8,2])
C0003281 (UMLS CUI [8,3])
Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Heparin allergy | Contrast media allergy | Hypersensitivity Rapamycin | Metal allergy
Item
9. patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
C0571776 (UMLS CUI [4])
C0570562 (UMLS CUI [5])
C0020517 (UMLS CUI [6,1])
C0072980 (UMLS CUI [6,2])
C0577627 (UMLS CUI [7])
Life Expectancy
Item
10. patients whose life expectancy less than 12 months;
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
11. patients who are participating in other drugs or medical devices clinical trials;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Protocol Compliance Unable
Item
12. patients who can not comply with the clinical trial protocol;
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Heart Transplantation
Item
13. patients having a heart transplant.
boolean
C0018823 (UMLS CUI [1])
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