ID

23150

Descripción

Responsible Party: Susanne Bonekamp, Prof. Dr. Martin Bendszus, University Hospital Heidelberg ClinicalTrials.gov Identifier: NCT02135926 History of Changes Other Study ID Numbers: UH-Heidelberg-THRILL DRKS00005792 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: April 30, 2014 Last Updated: February 15, 2017 Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment (THRILL) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02135926

Link

https://clinicaltrials.gov/ct2/show/NCT02135926

Palabras clave

Versiones (2)
  1. 26/6/17 26/6/17 -
  2. 20/9/21 20/9/21 -
Subido en

26 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibilty Thrombectomy for Ischemic Stroke DRKS00005792 NCT02135926 DRKS00005792

Inglés

Eligibilty Thrombectomy for Ischemic Stroke NCT02135926 DRKS00005792

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patient is ineligible for treatment with IV tPA according to licensing criteria (e.g. anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).
Descripción

Ineligible for tPA treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0749606
UMLS CUI [1,2]
C1512714
Randomization within 7 hours after stroke onset.
Descripción

Randomization: Time of Onset

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0449244
Endovascular treatment is expected to be finished within 8 hours after symptom onset by judgment of the interventional Neuroradiologist in charge.
Descripción

Thrombectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162578
Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.
Descripción

Symptoms of an Ischemic Stroke

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0948008
Female and male patient between 18-80 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
NIHSS Score of >7 and <25
Descripción

NIHSS Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3476804
Patient signed informed consent (IC) form by patient, legal representative, or by an independent physician who is familiar with this types of illness if the other options are not possible.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA).
Descripción

Neuroradiology: Site of Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2183225
UMLS CUI [1,2]
C0449685
Prior to new focal neurological deficit, mRS score was ≤1.
Descripción

Modified Rankin Scale Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3828944
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Descripción

Control Group

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009932
Patient is eligible for and receives IV tPA according to licensing criteria
Descripción

tPA Treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0749606
Patient with an international normalized ratio (INR) of >3
Descripción

INR

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525032
Patient is an active participant in another drug or device treatment trial for any disease state, or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
Descripción

Study Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
Descripción

Neurological or psychatric disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
Descripción

Carotid dissection or stenosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0338585
UMLS CUI [2]
C0007282
Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
Descripción

Vascular disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042373
Patient has history of contraindication for contrast medium.
Descripción

Contraindication for Contrast medium

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C1301624
Patient is known to have infective endocarditis
Descripción

Infective endocarditis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1541923
CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on unenhanced CT and cerebral blood volume (CBV) drop on CBV maps on Computed Tomography Perfusion (CTP), or, alternatively as per institutional standard, restricted diffusion on Diffusion weighted imaging (DWI) with an Alberta Stroke Program Early CT score (ASPECTs) of 6 or less
Descripción

Neuroradiology finding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2183225
UMLS CUI [1,2]
C0243095
Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.
Descripción

Gynaecological Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Patient‟s anticipated life expectancy is less than 6 Months.
Descripción

Life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibilty Thrombectomy for Ischemic Stroke NCT02135926 DRKS00005792

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Ineligible for tPA treatment
Item
Patient is ineligible for treatment with IV tPA according to licensing criteria (e.g. anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).
boolean
C0749606 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Randomization: Time of Onset
Item
Randomization within 7 hours after stroke onset.
boolean
C0034656 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
Thrombectomy
Item
Endovascular treatment is expected to be finished within 8 hours after symptom onset by judgment of the interventional Neuroradiologist in charge.
boolean
C0162578 (UMLS CUI [1])
Symptoms of an Ischemic Stroke
Item
Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.
boolean
C1457887 (UMLS CUI [1,1])
C0948008 (UMLS CUI [1,2])
Age
Item
Female and male patient between 18-80 years of age
boolean
C0001779 (UMLS CUI [1])
NIHSS Score
Item
NIHSS Score of >7 and <25
boolean
C3476804 (UMLS CUI [1])
Informed Consent
Item
Patient signed informed consent (IC) form by patient, legal representative, or by an independent physician who is familiar with this types of illness if the other options are not possible.
boolean
C0021430 (UMLS CUI [1])
Neuroradiology: Site of Lesion
Item
A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA).
boolean
C2183225 (UMLS CUI [1,1])
C0449685 (UMLS CUI [1,2])
Modified Rankin Scale Score
Item
Prior to new focal neurological deficit, mRS score was ≤1.
boolean
C3828944 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
tPA Treatment
Item
Patient is eligible for and receives IV tPA according to licensing criteria
boolean
C0749606 (UMLS CUI [1])
INR
Item
Patient with an international normalized ratio (INR) of >3
boolean
C0525032 (UMLS CUI [1])
Study Participation Status
Item
Patient is an active participant in another drug or device treatment trial for any disease state, or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
boolean
C2348568 (UMLS CUI [1])
Neurological or psychatric disease
Item
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Carotid dissection or stenosis
Item
Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
boolean
C0338585 (UMLS CUI [1])
C0007282 (UMLS CUI [2])
Vascular disease
Item
Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
boolean
C0042373 (UMLS CUI [1])
Contraindication for Contrast medium
Item
Patient has history of contraindication for contrast medium.
boolean
C0009924 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Infective endocarditis
Item
Patient is known to have infective endocarditis
boolean
C1541923 (UMLS CUI [1])
Neuroradiology finding
Item
CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on unenhanced CT and cerebral blood volume (CBV) drop on CBV maps on Computed Tomography Perfusion (CTP), or, alternatively as per institutional standard, restricted diffusion on Diffusion weighted imaging (DWI) with an Alberta Stroke Program Early CT score (ASPECTs) of 6 or less
boolean
C2183225 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Gynaecological Status
Item
Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life expectancy
Item
Patient‟s anticipated life expectancy is less than 6 Months.
boolean
C0023671 (UMLS CUI [1])
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