ID

42138

Description

A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT01909869

Link

https://clinicaltrials.gov/show/NCT01909869

Keywords

Versions (2)
  1. 4/24/20 4/24/20 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Ischemia NCT01909869

English

Eligibility Ischemia NCT01909869

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Ischemia NCT01909869
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 18yrs≤age≤75yrs .
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. de novo lesion at native coronary artery.
Description

Lesion de novo | Coronary artery Native

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0205042
UMLS CUI [2,2]
C0302891
3. single target vessel and single target lesion.
Description

Target vessel Single | Target Lesion Single

Data type

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0205171
4. lesion length ≤32mm.
Description

Lesion Length

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1444754
5. rvd 2.5mm～4.0mm.
Description

Reference Vessel Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
6. ds%≥70% by visual estimation.
Description

Percent Diameter Stenosis Measurement Visual estimation

Data type

boolean

Alias
UMLS CUI [1,1]
C3897965
UMLS CUI [1,2]
C0444684
7. target lesion could be covered by only one stent.
Description

Target Lesion Covered | Stent Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1999244
UMLS CUI [1,3]
C0038257
UMLS CUI [1,4]
C1265611
8. subjects are willing to follow the specified requirements follow-up.
Description

Compliance behavior Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
9. a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. informed consent is documented by means of a written, signed and dated informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. ami within one week.
Description

Recent myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C1998297
2. cto(timi0),lm lesion,ostial lesion,graft vessel lesion,bifurcation (side branch rvd≥2.5mm),isr,mutivessel disease need to be treated.
Description

Chronic Total Occlusion Vessel TIMI grade | Left main coronary artery Lesion | Ostium Lesion | Graft Vessel Lesion | Bifurcation Lesion | In Stent restenosis | Multiple Vessel Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3275069
UMLS CUI [1,2]
C4263591
UMLS CUI [2,1]
C1261082
UMLS CUI [2,2]
C0221198
UMLS CUI [3,1]
C0444567
UMLS CUI [3,2]
C0221198
UMLS CUI [4,1]
C0332835
UMLS CUI [4,2]
C0005847
UMLS CUI [4,3]
C0221198
UMLS CUI [5,1]
C3146289
UMLS CUI [5,2]
C0221198
UMLS CUI [6]
C3272317
UMLS CUI [7,1]
C0005847
UMLS CUI [7,2]
C0439064
UMLS CUI [7,3]
C0012634
3. severe calcified lesion unable to predilate.
Description

Lesion Calcified Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205082
4. extremely tortuous proximal to the lesion that is inadequate to stent delivery.
Description

Lesion Inadequate Placement of stent

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0522776
5. nyha≥ⅲ or lvef≤40%.
Description

New York Heart Association Classification | Left ventricular ejection fraction

Data type

boolean

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

Stenting Previous

Data type

boolean

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

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

Data type

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]
C1301732
UMLS CUI [4,3]
C0032790
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.
Description

Bleeding tendency | Blood Coagulation Disorders | Medical contraindication Percutaneous Coronary Intervention | Taboo Anticoagulant therapy | Dual Antiplatelet therapy Discontinue Unable

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1532338
UMLS CUI [4,1]
C0039227
UMLS CUI [4,2]
C0150457
UMLS CUI [5,1]
C1096021
UMLS CUI [5,2]
C0205173
UMLS CUI [5,3]
C1444662
UMLS CUI [5,4]
C1299582
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).
Description

Malignant Neoplasms | Congestive heart failure | Organ Transplantation | Organ Transplantation Scheduled | Substance Use Disorders | Poor compliance | Life Expectancy Limited

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0029216
UMLS CUI [4,1]
C0029216
UMLS CUI [4,2]
C0205539
UMLS CUI [5]
C0038586
UMLS CUI [6]
C0032646
UMLS CUI [7,1]
C0023671
UMLS CUI [7,2]
C0439801
10. to aspirin heparin clopidogrel cobalt chromium alloy rapamycin pla polymer contrast agent of one of allergy.
Description

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

Data type

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]
C0009148
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0008575
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0072980
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0071443
UMLS CUI [8]
C0570562
11. serious liver and kidney function is not complete person.
Description

Liver Dysfunction Serious | Renal Insufficiency Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205404
12. the investigators think that do not fit to enroll the study.
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Ischemia NCT01909869

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Ischemia NCT01909869
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. 18yrs≤age≤75yrs .
boolean
C0001779 (UMLS CUI [1])
Lesion de novo | Coronary artery Native
Item
2. de novo lesion at native coronary artery.
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205042 (UMLS CUI [2,1])
C0302891 (UMLS CUI [2,2])
Target vessel Single | Target Lesion Single
Item
3. single target vessel and single target lesion.
boolean
C0449618 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Lesion Length
Item
4. lesion length ≤32mm.
boolean
C0221198 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Reference Vessel Diameter
Item
5. rvd 2.5mm～4.0mm.
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Percent Diameter Stenosis Measurement Visual estimation
Item
6. ds%≥70% by visual estimation.
boolean
C3897965 (UMLS CUI [1,1])
C0444684 (UMLS CUI [1,2])
Target Lesion Covered | Stent Quantity
Item
7. target lesion could be covered by only one stent.
boolean
C2986546 (UMLS CUI [1,1])
C1999244 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Compliance behavior Follow-up
Item
8. subjects are willing to follow the specified requirements follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Informed Consent
Item
9. a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. informed consent is documented by means of a written, signed and dated informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recent myocardial infarction
Item
1. ami within one week.
boolean
C1998297 (UMLS CUI [1])
Chronic Total Occlusion Vessel TIMI grade | Left main coronary artery Lesion | Ostium Lesion | Graft Vessel Lesion | Bifurcation Lesion | In Stent restenosis | Multiple Vessel Disease
Item
2. cto(timi0),lm lesion,ostial lesion,graft vessel lesion,bifurcation (side branch rvd≥2.5mm),isr,mutivessel disease need to be treated.
boolean
C3275069 (UMLS CUI [1,1])
C4263591 (UMLS CUI [1,2])
C1261082 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0444567 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0332835 (UMLS CUI [4,1])
C0005847 (UMLS CUI [4,2])
C0221198 (UMLS CUI [4,3])
C3146289 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
C3272317 (UMLS CUI [6])
C0005847 (UMLS CUI [7,1])
C0439064 (UMLS CUI [7,2])
C0012634 (UMLS CUI [7,3])
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])
Lesion Inadequate Placement of stent
Item
4. extremely tortuous proximal to the lesion that is inadequate to stent delivery.
boolean
C0221198 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0522776 (UMLS CUI [1,3])
New York Heart Association Classification | Left ventricular ejection fraction
Item
5. nyha≥ⅲ or lvef≤40%.
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 Planned Postoperative
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])
C1301732 (UMLS CUI [4,2])
C0032790 (UMLS CUI [4,3])
Bleeding tendency | Blood Coagulation Disorders | Medical contraindication Percutaneous Coronary Intervention | Taboo Anticoagulant therapy | Dual Antiplatelet therapy Discontinue Unable
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])
C0039227 (UMLS CUI [4,1])
C0150457 (UMLS CUI [4,2])
C1096021 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C1444662 (UMLS CUI [5,3])
C1299582 (UMLS CUI [5,4])
Malignant Neoplasms | Congestive heart failure | Organ Transplantation | Organ Transplantation Scheduled | Substance Use Disorders | Poor compliance | 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])
C0205539 (UMLS CUI [4,2])
C0038586 (UMLS CUI [5])
C0032646 (UMLS CUI [6])
C0023671 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
Aspirin allergy | Heparin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Cobalt | Hypersensitivity Chromium Alloys | Hypersensitivity Sirolimus | Hypersensitivity Polylactic acid | 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])
C0009148 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0008575 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0072980 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0071443 (UMLS CUI [7,2])
C0570562 (UMLS CUI [8])
Liver Dysfunction Serious | Renal Insufficiency Serious
Item
11. serious liver and kidney function is not complete person.
boolean
C0086565 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Study Subject Participation Status Inappropriate
Item
12. the investigators think that do not fit to enroll the study.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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