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Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset

NCT ID: NCT02164357

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-12-31

Brief Summary

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This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.

Detailed Description

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Conditions

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Acute Ischaemic Stroke

Keywords

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Ischaemic Stroke Main artery occlusion Endovascular treatment Intravenous Thrombolytic Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EVT

Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated

EVT (endovascular treatment )

Intervention Type PROCEDURE

IVT + EVT

Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset

EVT (endovascular treatment )

Intervention Type PROCEDURE

IVT (intravenous thrombolytic therapy)

Intervention Type PROCEDURE

IVT (intravenous thrombolytic therapy)

Patients that will received IVT only within 4.5 hours after onset

IVT (intravenous thrombolytic therapy)

Intervention Type PROCEDURE

Interventions

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EVT (endovascular treatment )

Intervention Type PROCEDURE

IVT (intravenous thrombolytic therapy)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 80 or less years old patients with acute stroke produced by a main artery occlusion
* NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment)
* Patients receiving EVT or IVT within 4.5 hours after onset

Exclusion Criteria

* EVT or IVT contraindication
* Previous neurological impairment, severe concomitant disease or poor prognosis.
* Pregnancy or breastfeeding
* Known hypersensitivity to any study drugs
* Severe organic disease for which there is not risk compensation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Gregorio Marañón

Madrid, Madrid, Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Site Status

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Site Status

Hospital Universitario Doce de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Alonso de Lecinana M, Martinez-Sanchez P, Garcia-Pastor A, Kawiorski MM, Calleja P, Sanz-Cuesta BE, Diaz-Otero F, Frutos R, Sierra-Hidalgo F, Ruiz-Ares G, Fandino E, Diez-Tejedor E, Gil-Nunez A, Fuentes B. Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis: a prospective observational study. J Neurointerv Surg. 2017 Nov;9(11):1041-1046. doi: 10.1136/neurintsurg-2016-012727. Epub 2016 Nov 7.

Reference Type DERIVED
PMID: 27821473 (View on PubMed)

Kawiorski MM, Martinez-Sanchez P, Garcia-Pastor A, Calleja P, Fuentes B, Sanz-Cuesta BE, Lourido D, Marin B, Diaz-Otero F, Vicente A, Sierra-Hidalgo F, Ruiz-Ares G, Diez-Tejedor E, Fandino E, Alonso de Lecinana M. Alberta Stroke Program Early CT Score applied to CT angiography source images is a strong predictor of futile recanalization in acute ischemic stroke. Neuroradiology. 2016 May;58(5):487-93. doi: 10.1007/s00234-016-1652-7. Epub 2016 Feb 2.

Reference Type DERIVED
PMID: 26838587 (View on PubMed)

Other Identifiers

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FUN-TPA-2012-01

Identifier Type: -

Identifier Source: org_study_id