ID

35576

Beskrivning

MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT02400632

Länk

https://clinicaltrials.gov/show/NCT02400632

Nyckelord

Versioner (1)
  1. 2019-03-10 2019-03-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02400632

Engelsk

Eligibility Coronary Artery Disease NCT02400632

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patient must be ≥18 and ≤ 80 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. symptomatic ischemic heart disease;
Beskrivning

Myocardial Ischemia Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0231220
3. acceptable candidate for coronary artery bypass graft (cabg) or angioplasty;
Beskrivning

Patient Acceptable Coronary Artery Bypass Surgery | Patient Acceptable Angioplasty

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1879533
UMLS CUI [1,3]
C0010055
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1879533
UMLS CUI [2,3]
C0162577
4. target lesion located in a native coronary artery
Beskrivning

Target Lesion Location Coronary artery Native

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205042
UMLS CUI [1,4]
C0302891
5. target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon;
Beskrivning

Target Lesion Length Maximum | Target Lesion covered by Balloon Single

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1555028
UMLS CUI [2,3]
C0441144
UMLS CUI [2,4]
C0205171
6. reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate;
Beskrivning

Reference Vessel Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
7. target lesion ≥50% and <100% stenosed by visual estimate
Beskrivning

Target Lesion Stenosed Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0333181
UMLS CUI [1,3]
C0439165
8. restenosis of initially stented main vessel.
Beskrivning

Restenosis | Vessel Main Stented

Datatyp

boolean

Alias
UMLS CUI [1]
C0333186
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C0038257
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
2. patient has had a known diagnosis of acute myocardial infarction (ami) within 72 hours preceding the index procedure;
Beskrivning

Acute myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0155626
3. lesions in bypass grafts or bifurcations
Beskrivning

Lesion Bypass graft | Bifurcation lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0185098
UMLS CUI [2]
C1299363
4. any non-target vessel or lesion intended to be treated during the index procedure, which is an unprotected left main, ostial lesion, chronic total occlusion (cto), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
Beskrivning

Treatment intended Vessel | Exception Target vessel | Treatment intended Lesion | Left coronary artery main stem | Ostium Lesion | Chronic total occlusion | Vessel Calcified | Bifurcation | Graft Venous | Thrombus Angiography | Atherectomy | Thrombectomy | Pre treatment | Exception Balloon Angioplasty

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C0005847
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0449618
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1283828
UMLS CUI [3,3]
C0221198
UMLS CUI [4]
C0226031
UMLS CUI [5,1]
C0444567
UMLS CUI [5,2]
C0221198
UMLS CUI [6]
C1955779
UMLS CUI [7,1]
C0005847
UMLS CUI [7,2]
C0175895
UMLS CUI [8]
C3146289
UMLS CUI [9,1]
C0332835
UMLS CUI [9,2]
C0348013
UMLS CUI [10,1]
C0087086
UMLS CUI [10,2]
C0002978
UMLS CUI [11]
C0162513
UMLS CUI [12]
C0162578
UMLS CUI [13]
C2709094
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0002996
5. patient presents with cardiogenic shock;
Beskrivning

Shock, Cardiogenic

Datatyp

boolean

Alias
UMLS CUI [1]
C0036980
6. patient has extensive peripheral vascular disease that precludes safe 6 french sheath insertion
Beskrivning

Peripheral Vascular Disease Extensive | Secure sheath insertion excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205231
UMLS CUI [2,1]
C0463345
UMLS CUI [2,2]
C0441587
UMLS CUI [2,3]
C0332196
7. unprotected left main coronary artery disease with ≥50% stenosis;
Beskrivning

Left main coronary artery disease | Stenosis Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C1299433
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
8. totally occluded target vessel (timi flow 0);
Beskrivning

Target vessel Occluded Total | TIMI Flow

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1947917
UMLS CUI [1,3]
C0439810
UMLS CUI [2]
C3272266
9. calcified target lesion(s) which cannot be successfully pre-dilated;
Beskrivning

Target Lesion Calcified | Dilate procedure Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0175895
UMLS CUI [2,1]
C1322279
UMLS CUI [2,2]
C1272705
10. a significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon
Beskrivning

Stenosis Percentage Proximal Target Lesion | Stenosis Percentage Distal Target Lesion | Coverage Balloon Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0205107
UMLS CUI [1,4]
C2986546
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0205108
UMLS CUI [2,4]
C2986546
UMLS CUI [3,1]
C1999244
UMLS CUI [3,2]
C0441144
UMLS CUI [3,3]
C1272705
11. diffuse distal disease to target lesion with impaired runoff;
Beskrivning

Diffuse disease Distal Target Lesion | Blood flow Impaired

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299384
UMLS CUI [1,2]
C0205108
UMLS CUI [1,3]
C2986546
UMLS CUI [2,1]
C0232338
UMLS CUI [2,2]
C0221099
12. left ventricular ejection fraction (lvef) ≤30% (lvef must be obtained within 1 months prior to the index procedure).
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
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Similar models

Eligibility Coronary Artery Disease NCT02400632

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. the patient must be ≥18 and ≤ 80 years of age
boolean
C0001779 (UMLS CUI [1])
Myocardial Ischemia Symptomatic
Item
2. symptomatic ischemic heart disease;
boolean
C0151744 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient Acceptable Coronary Artery Bypass Surgery | Patient Acceptable Angioplasty
Item
3. acceptable candidate for coronary artery bypass graft (cabg) or angioplasty;
boolean
C0030705 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0162577 (UMLS CUI [2,3])
Target Lesion Location Coronary artery Native
Item
4. target lesion located in a native coronary artery
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
Target Lesion Length Maximum | Target Lesion covered by Balloon Single
Item
5. target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon;
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1555028 (UMLS CUI [2,2])
C0441144 (UMLS CUI [2,3])
C0205171 (UMLS CUI [2,4])
Reference Vessel Diameter
Item
6. reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate;
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Target Lesion Stenosed Percentage
Item
7. target lesion ≥50% and <100% stenosed by visual estimate
boolean
C2986546 (UMLS CUI [1,1])
C0333181 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Restenosis | Vessel Main Stented
Item
8. restenosis of initially stented main vessel.
boolean
C0333186 (UMLS CUI [1])
C0005847 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C0038257 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
1. pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Acute myocardial infarction
Item
2. patient has had a known diagnosis of acute myocardial infarction (ami) within 72 hours preceding the index procedure;
boolean
C0155626 (UMLS CUI [1])
Lesion Bypass graft | Bifurcation lesion
Item
3. lesions in bypass grafts or bifurcations
boolean
C0221198 (UMLS CUI [1,1])
C0185098 (UMLS CUI [1,2])
C1299363 (UMLS CUI [2])
Treatment intended Vessel | Exception Target vessel | Treatment intended Lesion | Left coronary artery main stem | Ostium Lesion | Chronic total occlusion | Vessel Calcified | Bifurcation | Graft Venous | Thrombus Angiography | Atherectomy | Thrombectomy | Pre treatment | Exception Balloon Angioplasty
Item
4. any non-target vessel or lesion intended to be treated during the index procedure, which is an unprotected left main, ostial lesion, chronic total occlusion (cto), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;
boolean
C0087111 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0449618 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0221198 (UMLS CUI [3,3])
C0226031 (UMLS CUI [4])
C0444567 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
C1955779 (UMLS CUI [6])
C0005847 (UMLS CUI [7,1])
C0175895 (UMLS CUI [7,2])
C3146289 (UMLS CUI [8])
C0332835 (UMLS CUI [9,1])
C0348013 (UMLS CUI [9,2])
C0087086 (UMLS CUI [10,1])
C0002978 (UMLS CUI [10,2])
C0162513 (UMLS CUI [11])
C0162578 (UMLS CUI [12])
C2709094 (UMLS CUI [13])
C1705847 (UMLS CUI [14,1])
C0002996 (UMLS CUI [14,2])
Shock, Cardiogenic
Item
5. patient presents with cardiogenic shock;
boolean
C0036980 (UMLS CUI [1])
Peripheral Vascular Disease Extensive | Secure sheath insertion excluded
Item
6. patient has extensive peripheral vascular disease that precludes safe 6 french sheath insertion
boolean
C0085096 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0463345 (UMLS CUI [2,1])
C0441587 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Left main coronary artery disease | Stenosis Percentage
Item
7. unprotected left main coronary artery disease with ≥50% stenosis;
boolean
C1299433 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Target vessel Occluded Total | TIMI Flow
Item
8. totally occluded target vessel (timi flow 0);
boolean
C0449618 (UMLS CUI [1,1])
C1947917 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2])
Target Lesion Calcified | Dilate procedure Unsuccessful
Item
9. calcified target lesion(s) which cannot be successfully pre-dilated;
boolean
C2986546 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C1322279 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Stenosis Percentage Proximal Target Lesion | Stenosis Percentage Distal Target Lesion | Coverage Balloon Unsuccessful
Item
10. a significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon
boolean
C1261287 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0205107 (UMLS CUI [1,3])
C2986546 (UMLS CUI [1,4])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0205108 (UMLS CUI [2,3])
C2986546 (UMLS CUI [2,4])
C1999244 (UMLS CUI [3,1])
C0441144 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Diffuse disease Distal Target Lesion | Blood flow Impaired
Item
11. diffuse distal disease to target lesion with impaired runoff;
boolean
C1299384 (UMLS CUI [1,1])
C0205108 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0232338 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
12. left ventricular ejection fraction (lvef) ≤30% (lvef must be obtained within 1 months prior to the index procedure).
boolean
C0428772 (UMLS CUI [1])
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