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Endovascular Treatment in Ischemic Stroke Follow-up Evaluation (ETIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776877
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Study Description
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Brief Summary:
Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes.

Condition or disease
Stroke, Acute

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 90 Days
Official Title: Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Groups and Cohorts
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Group/Cohort
Arterial Ischemic Stroke (AIS)

All patients (prospective and retrospective) included will have to present an Arterial Ischemic Stroke (AIS) from a large cerebral vessel occlusion.

The participation in the study will consist in:

  • Plasmatic collection at the time of AIS, for study of plasma biomarkers
  • Additional standardized blinded clinical evaluation at three months after the thrombectomy realized during a phone call, particularly via an assessment of the modified Rankin score.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical outcome [ Time Frame: Day 90 ]
    modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.


Secondary Outcome Measures :
  1. Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3) [ Time Frame: Day 1 ]
    Rate of complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)

  2. Efficacy on revascularization (>= mTICI 2b) [ Time Frame: Day 1 ]
    Time to achieve TICI 2b or better revascularization

  3. Efficacy on clinical outcome (mRS=0-1) [ Time Frame: Day 90 ]
    Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1

  4. Efficacy on functional independence (mRS 0-2) [ Time Frame: Day 90 ]
    Rate of functional independence defined as a modified Rankin score 0-2

  5. Hemorrhage evaluated by imagery [ Time Frame: Day 0 ]
    Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan

  6. Hematoma rate [ Time Frame: Day 1 ]
    Rate of parenchymal hematoma 2

  7. Mortality rate [ Time Frame: Day 90 ]
    Rate of all-cause mortality

  8. Complication rate [ Time Frame: Day 0 ]
    Rate of periprocedural complications

  9. ASPECT (Alberta Stroke Program Early CT score) [ Time Frame: Day O ]
    Measure by Axial imaging, 10-point quantitative topographic CT scan score

  10. Parametric imaging [ Time Frame: Day 0 ]
    Diffusion, volume clinical-diffusion mismatch

  11. Imaging data [ Time Frame: Day 1 ]
    Angiographic imaging

  12. Blood sampling for research purpose [ Time Frame: Day 0 ]
    Search of biomarkers of stroke etiology and recovery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with stroke treated by thrombectomy.
Criteria

Inclusion Criteria:

  • Age 18 and older (i.e., candidates must have had their 18th birthday)
  • Neuroimaging demonstrates acute ischemic stroke with large vessel proximal with the use of neuro-thrombectomy devices intended to restore blood flow
  • No upper or lower limits of the neurological severity at baseline (NIHSS).
  • With or without intravenous thrombolysis
  • Oral informed consent (patient and/or trustworthy person)

Non-inclusion Criteria:

  • Pregnant or breast-feeding women
  • Patient benefiting from a legal protection
  • Non-membership of a national insurance scheme
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776877


Contacts
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Contact: Elisabeth Hulier-Ammar +33146251175 drci-promotion@hopital-foch.com

Locations
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France
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Gaultier Marnat, MD       gaultier.marnat@chu-bordeaux.fr   
Principal Investigator: Gaultier Marnat, MD         
CHU de Caen Recruiting
Caen, France
Contact: Emmanuel TOUZE, PhD       touze-e@chu-caen.fr   
Principal Investigator: Emmanuel TOUZE, MD         
Hôpital le Kremlin-Bicètre - APHP Recruiting
Le Kremlin-Bicêtre, France
Contact: Laurent Spelle, MD       laurent.spelle@aphp.fr   
Principal Investigator: Laurent Spelle, MD         
CHU Dupuytren Recruiting
Limoges, France, 87042
Contact: Charbel MOUNAYER, MD       charbel.mounayer@unilim.fr   
Principal Investigator: Charbel MOUNAYER, MD         
CHU Lyon Not yet recruiting
Lyon, France
Contact: Omer Eker, MD       Omer.eker@chu-lyon.fr   
Principal Investigator: Omer Eker, MD         
CHU Montpellier Recruiting
Montpellier, France
Contact: Cyril Dargazanli, MD       cyril.dargazanli@gmail.com   
Principal Investigator: Cyril Darganzanli, MD         
CHU Nancy Recruiting
Nancy, France
Contact: Benjamin Gory, MD       b.gory@chu-nancy.fr   
Principal Investigator: Benjamin Gory, MD         
CHU Nantes Recruiting
Nantes, France
Contact: Romain Bourcier, MD       Romain.bourcier@chu-nantes.fr   
Principal Investigator: Romain Bourcier, MD         
Hôpital Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Frédéric CLARENCON, MD       frederic.clarencon@aphp.fr   
Principal Investigator: Frédéric CLARENCON, MD         
Hôpital SAINTE ANNE Recruiting
Paris, France, 75014
Contact: Olivier NAGARRA, MD       O.NAGGARA@ch-sainte-anne.fr   
Principal Investigator: Olivier NAGARRA, MD         
Fondation Ophtalmique de Rotschild Recruiting
Paris, France
Contact: Raphael Blanc, MD       rblanc@fo-rothschild.fr   
Principal Investigator: Raphael Blanc, MD         
CHU Rennes Recruiting
Rennes, France
Contact: Jean-Christophe Ferre, MD       Jean-christophe.FERRE@chu-rennes.fr   
Principal Investigator: JC Ferre, MD         
Chu Rouen Recruiting
Rouen, France, 76100
Contact: Olzem OZKUL-WERMESTER, MD       Ozlem.OzkulWermester@chu-rouen.fr   
Principal Investigator: Olzem OZKUL-WERMESTER, MD         
Hôpital Foch Recruiting
Suresnes, France, 92150
Contact: Bertrand Lapergue, MD    +33(0)1 46 25 73 43    b.lapergue@hopital-foch.org   
Principal Investigator: Bertrand Lapergue, MD         
CHU Toulouse Recruiting
Toulouse, France, 31300
Contact: Alain VIGUIER, MD       viguier.a@chu-toulouse.fr   
Principal Investigator: Alain VIGUIER, MD         
CH Bretagne Atlantique Active, not recruiting
Vannes, France, 56017
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Bertrand Larpergue, MD Hopital Foch
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03776877    
Other Study ID Numbers: 2017024F
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases