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ETIS: Endovascular Treatment in Ischemic Stroke Follow-up Evaluation

Sponsor
Hopital Foch (Other)
Overall Status
Recruiting
CT.gov ID
NCT03776877
Collaborator
(none)
4,000
Enrollment
16
Locations
53.2
Anticipated Duration (Months)
250
Patients Per Site
4.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    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 :
    Jun 26, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Clinical outcome [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) [Day 1]

      Rate of complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)

    2. Efficacy on revascularization (>= mTICI 2b) [Day 1]

      Time to achieve TICI 2b or better revascularization

    3. Efficacy on clinical outcome (mRS=0-1) [Day 90]

      Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1

    4. Efficacy on functional independence (mRS 0-2) [Day 90]

      Rate of functional independence defined as a modified Rankin score 0-2

    5. Hemorrhage evaluated by imagery [Day 0]

      Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan

    6. Hematoma rate [Day 1]

      Rate of parenchymal hematoma 2

    7. Mortality rate [Day 90]

      Rate of all-cause mortality

    8. Complication rate [Day 0]

      Rate of periprocedural complications

    9. ASPECT (Alberta Stroke Program Early CT score) [Day O]

      Measure by Axial imaging, 10-point quantitative topographic CT scan score

    10. Parametric imaging [Day 0]

      Diffusion, volume clinical-diffusion mismatch

    11. Imaging data [Day 1]

      Angiographic imaging

    12. Blood sampling for research purpose [Day 0]

      Search of biomarkers of stroke etiology and recovery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 CHU Bordeaux Bordeaux France
    2 CHU de Caen Caen France
    3 Hôpital le Kremlin-Bicètre - APHP Le Kremlin-Bicêtre France
    4 CHU Dupuytren Limoges France 87042
    5 CHU Lyon Lyon France
    6 CHU Montpellier Montpellier France
    7 CHU Nancy Nancy France
    8 CHU Nantes Nantes France
    9 Hôpital Pitié Salpétrière Paris France 75013
    10 Hôpital SAINTE ANNE Paris France 75014
    11 Fondation Ophtalmique de Rotschild Paris France
    12 CHU Rennes Rennes France
    13 Chu Rouen Rouen France 76100
    14 Hôpital Foch Suresnes France 92150
    15 CHU Toulouse Toulouse France 31300
    16 CH Bretagne Atlantique Vannes France 56017

    Sponsors and Collaborators

    • Hopital Foch

    Investigators

    • Principal Investigator: Bertrand Larpergue, MD, Hopital Foch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hopital Foch
    ClinicalTrials.gov Identifier:
    NCT03776877
    Other Study ID Numbers:
    • 2017024F
    First Posted:
    Dec 17, 2018
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Aug 3, 2022