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Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study) (VasIntervent)

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intracranial Stenting by Intracranial Stent Device
Optimum medical treatment
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients age between 30-80 years.
  2. Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) [M1segment], vertebral artery (VA), or basilar artery (BA).
  3. Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia).

Exclusion Criteria:

  1. Patients previously stented at the target lesion or had extracranial stenosis.
  2. Patient with acute stroke (within two weeks from the onset).
  3. Complete occlusion of the artery on the imaging assessment.
  4. Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans.
  5. Contraindications to antithrombotic and/or anticoagulant therapies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Intracranial Stenting

    Aspirin+Clopidogrel

    Arm Description

    25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS

    25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment

    Outcomes

    Primary Outcome Measures

    Clinical improvement of IC stented patients in comparison to medically treated
    clinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr
    Functional improvement of IC stented patients in comparison to medically treated
    Functional assessment by modified Rankin Scale (mRS) for functional improvement
    Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated
    Transcranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels

    Secondary Outcome Measures

    No Recurrent Ischemic stroke in stented ICSD patients
    Clinical Assessment

    Full Information

    First Posted
    December 16, 2019
    Last Updated
    May 14, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04393025
    Brief Title
    Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study)
    Acronym
    VasIntervent
    Official Title
    Endovascular Stenting of Medically Refractory Intracranial Arterial Stenotic (ICAS) Disease (Clinical and Sonographic Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    June 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams 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
    Yes

    5. Study Description

    Brief Summary
    Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients
    Detailed Description
    Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two armed medical study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intracranial Stenting
    Arm Type
    Other
    Arm Description
    25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS
    Arm Title
    Aspirin+Clopidogrel
    Arm Type
    Active Comparator
    Arm Description
    25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment
    Intervention Type
    Device
    Intervention Name(s)
    Intracranial Stenting by Intracranial Stent Device
    Other Intervention Name(s)
    cardiac and wingspan IC stent device
    Intervention Description
    Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted
    Intervention Type
    Drug
    Intervention Name(s)
    Optimum medical treatment
    Other Intervention Name(s)
    Clopidogrel 75 mg +Aspirin 161 mg
    Intervention Description
    Optimum Medical treatment
    Primary Outcome Measure Information:
    Title
    Clinical improvement of IC stented patients in comparison to medically treated
    Description
    clinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr
    Time Frame
    3 months
    Title
    Functional improvement of IC stented patients in comparison to medically treated
    Description
    Functional assessment by modified Rankin Scale (mRS) for functional improvement
    Time Frame
    3 months
    Title
    Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated
    Description
    Transcranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    No Recurrent Ischemic stroke in stented ICSD patients
    Description
    Clinical Assessment
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients age between 30-80 years. Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) [M1segment], vertebral artery (VA), or basilar artery (BA). Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia). Exclusion Criteria: Patients previously stented at the target lesion or had extracranial stenosis. Patient with acute stroke (within two weeks from the onset). Complete occlusion of the artery on the imaging assessment. Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans. Contraindications to antithrombotic and/or anticoagulant therapies.

    12. IPD Sharing Statement

    Learn more about this trial

    Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study)

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