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Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".

Primary Purpose

Stroke, Acute Ischemic

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mechanical thrombectomy
medical treatment
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute Ischemic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years
  • Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA
  • With or without IV thrombolysis
  • Access to endovascular treatment within 24 hours from onset.

Exclusion Criteria:

  1. Proven proximal occlusion of MCA.
  2. Disability prior to the stroke (mRS >3)
  3. Opposition of the patient or their family

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Mechanical thrombectomy

    medical managemnet

    Arm Description

    this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.

    this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.

    Outcomes

    Primary Outcome Measures

    Clinical neurological outcome
    Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.

    Secondary Outcome Measures

    Functional outcome
    Functional outcome will be assessed using Modified Rankin Scale (mRS) which measures the degree of disability after stroke. Good functional outcome was defined as mRS less than 2 that will be assessed at one and three moth at discharge.

    Full Information

    First Posted
    September 23, 2021
    Last Updated
    October 12, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05091320
    Brief Title
    Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".
    Official Title
    Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA" :a Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    November 30, 2022 (Anticipated)
    Study Completion Date
    November 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively high rates of revascularization and favorable clinical outcomes after MT. , However second-order branches of the middle cerebral artery (M2) occlusions (postbifurcation in the Sylvian fissure) were underrepresented or not represented in the trials. Posing a more significant technical challenge to the available endovascular devices because of the smaller size and tortuosity of these arteries and the greater likelihood of recanalization with intravenous thrombolysis, the overall risk-benefit remains uncertain.
    Detailed Description
    this study aims to: compare efficacy of mechanical thrombectomy over medical treatment in occlusion of M2 division of MCA. improve outcome of acute ischemic stroke. The study will include all patients with AIS attending to emergency deparment with proven occlusion of M2 division of MCA, and deviding then into 2 groups: Group 1 will receive medical treatment (rTPA if presented in the first 4 hours, and antiplatelet if passed time window for IVT) Group 2 will underwent mechanical thrombectomy (if accessible), and even after receiving medical treatment and not improved and comparing the outcomes of these 2 groups c. Sample Size Calculation: Sample size was calculated using G*power, version 3.1.9.7. Estimation based on results of previous study which reported that, median (IQR) discharge NIHSS in mechanical thrombectomy group was 2 (0-4) compared to 1 (0-2) in medical management group giving medium effect size . With a power of 80% (using one-sided t-test, effect size = 0.65 and α of 0.5) the sample needed for the study was estimated to be 60 patients (30 in each group). Study design: All patients are subjected to the following: - Enrolled patients were admitted to stroke units or intensive care units. Intravenous t-PA was allowed if begun within < 4.5 hours after symptom onset. Thrombectomy will be performed with any FDA approved thrombectomy device by the use of local anesthesia (general anesthesia will be discouraged). Imaging Patients presented with clinical picture and radiography suggestive of large vessel occlusion and who meet the proposed clinical criteria for EVT will be subjected to a comprehensive evaluation with: Arterial imaging of the cerebral circulation with preferably with CTA or alternatively with magnetic resonance angiography to Perfusion imaging with perfusion CT or with diffusion weighted imaging MRI can allow identification and quantification of the ischemic penumbra and, therefore, is useful for assessing patient eligibility for EVT in the extended time window.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute Ischemic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    case control
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mechanical thrombectomy
    Arm Type
    Active Comparator
    Arm Description
    this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.
    Arm Title
    medical managemnet
    Arm Type
    Active Comparator
    Arm Description
    this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.
    Intervention Type
    Drug
    Intervention Name(s)
    Mechanical thrombectomy
    Intervention Description
    Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke
    Intervention Type
    Drug
    Intervention Name(s)
    medical treatment
    Intervention Description
    medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet
    Primary Outcome Measure Information:
    Title
    Clinical neurological outcome
    Description
    Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Functional outcome
    Description
    Functional outcome will be assessed using Modified Rankin Scale (mRS) which measures the degree of disability after stroke. Good functional outcome was defined as mRS less than 2 that will be assessed at one and three moth at discharge.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA With or without IV thrombolysis Access to endovascular treatment within 24 hours from onset. Exclusion Criteria: Proven proximal occlusion of MCA. Disability prior to the stroke (mRS >3) Opposition of the patient or their family

    12. IPD Sharing Statement

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    Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".

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