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Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

Primary Purpose

Acute Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mechanical Thrombectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged between 18 - 80 years old of both sex.
  2. Acute ischemic stroke due to proved large-artery occlusion.
  3. Ineligibility for IV thrombolysis.
  4. A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy.
  5. The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms.
  6. ASPECTS of 6 or > 6
  7. All patients will be undergoing CT/CT angiography before and after treatment

Exclusion Criteria:

  1. Age older than 80 years or less than 18
  2. Cerebral haemorrhage.
  3. Acute infarction > 1/3 of middle cerebral artery (MCA) territory on CT-scan.
  4. A history of stroke in the last 6 weeks.
  5. A time interval of > 4.5 hours.
  6. laboratory evidence of coagulation abnormalities.
  7. Known arteriovenous malformation , neoplasm or aneurysm.
  8. Woman at child bearing age who has a positive pregnancy test

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    mechanical thrombectomy

    Arm Description

    The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset, mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption.

    Outcomes

    Primary Outcome Measures

    Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy
    Treatment of ischemic stroke patients after 4.5 hours from stroke onset by endovascular intervention by using Mechanical Thrombectomy techniques and without using Recombinant tissue-type plasminogen Activator and non eligible patients for Thrombectomy will be excluded. The number of people will be participated into this study will be 20 aged 18 to 80 years old The patients will be undergoing NIHSS score , ASPECTS score The patients will be undergoing CT/CT angiography The patients will be undergoing mechanical thrombectomy Results will be collected and correlated with the prognosis of the outcomes

    Secondary Outcome Measures

    The patients will be undergoing NIHSS score
    patients with NIHSS score less than 10 non eligible for mechanical thrombectomy
    The patients will be undergoing ASPECTS score
    patients with ASPECTS score less than 6 non eligible for mechanical thrombectomy
    The patients will be undergoing CT/CT angiography
    ct and ct angiography for exclusion of any bleeding or head injury

    Full Information

    First Posted
    April 17, 2017
    Last Updated
    May 4, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03144960
    Brief Title
    Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
    Official Title
    Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2017 (Anticipated)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    December 2019 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.
    Detailed Description
    Stroke is an acute neurologic dysfunction of vascular origin with sudden or at least rapid occurrence of symptoms and signs corresponding to the involvement of focal areas in the brain.The two main types of stroke are ischemic and hemorrhagic.Thrombosis can form in the extracranial and intracranial arteries when the intima is roughened and plaque forms along the injured vessel.The endothelial injury permits platelets to adhere and aggregate, then coagulation is activated and thrombus develops at site of plaque.Blood flow through the extracranial and intracranial systems decreases, and the collateral circulation maintains function. When the compensatory mechanism of collateral circulation fails, perfusion is compromised, leading to decreased perfusion and cell death. Stroke is the third leading cause of death in the United States. Many people die each year from stroke in the United States.Stroke is the leading cause of serious, long-term disability in the United States. Nearly one fourth of strokes occur in people under the age of 65.High blood pressure is the most important risk factor for stroke. Intravenous recombinant tissue-type plasminogen activator is the only Food and Drug Administration approved treatment for acute ischemic stroke. Mechanical thrombectomy improves clinical outcomes in patients with acute ischemic stroke caused by a large vessel occlusion.There is no apparent benefit of intravenous thrombolysis to patients with ischemic stroke undergoing mechanical thrombectomy. The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mechanical thrombectomy
    Arm Type
    Other
    Arm Description
    The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset, mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption.
    Intervention Type
    Procedure
    Intervention Name(s)
    Mechanical Thrombectomy
    Intervention Description
    mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption
    Primary Outcome Measure Information:
    Title
    Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy
    Description
    Treatment of ischemic stroke patients after 4.5 hours from stroke onset by endovascular intervention by using Mechanical Thrombectomy techniques and without using Recombinant tissue-type plasminogen Activator and non eligible patients for Thrombectomy will be excluded. The number of people will be participated into this study will be 20 aged 18 to 80 years old The patients will be undergoing NIHSS score , ASPECTS score The patients will be undergoing CT/CT angiography The patients will be undergoing mechanical thrombectomy Results will be collected and correlated with the prognosis of the outcomes
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    The patients will be undergoing NIHSS score
    Description
    patients with NIHSS score less than 10 non eligible for mechanical thrombectomy
    Time Frame
    1 hour
    Title
    The patients will be undergoing ASPECTS score
    Description
    patients with ASPECTS score less than 6 non eligible for mechanical thrombectomy
    Time Frame
    1 hour
    Title
    The patients will be undergoing CT/CT angiography
    Description
    ct and ct angiography for exclusion of any bleeding or head injury
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged between 18 - 80 years old of both sex. Acute ischemic stroke due to proved large-artery occlusion. Ineligibility for IV thrombolysis. A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy. The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms. ASPECTS of 6 or > 6 All patients will be undergoing CT/CT angiography before and after treatment Exclusion Criteria: Age older than 80 years or less than 18 Cerebral haemorrhage. Acute infarction > 1/3 of middle cerebral artery (MCA) territory on CT-scan. A history of stroke in the last 6 weeks. A time interval of > 4.5 hours. laboratory evidence of coagulation abnormalities. Known arteriovenous malformation , neoplasm or aneurysm. Woman at child bearing age who has a positive pregnancy test
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Khedr, Professor
    Phone
    +201005850632
    Email
    emankhedr99@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17258667
    Citation
    Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4. Erratum In: Lancet. 2007 Mar 10;369(9564):826.
    Results Reference
    result

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    Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

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