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Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes

Primary Purpose

Ischemic Stroke, Thromboembolic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intracranial rescue stenting
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with acute ischemic stroke due to large vessel occlusion as confirmed by CT angiography or Magnetic resonance (MR) angiography.
  2. Baseline NIHSS >6.
  3. Presenting within the first 6 hours from onset of symptoms.
  4. First ever stroke or pre-stroke modified Rankin Score (mRS) ≤1.

Exclusion Criteria:

  1. Patients with intra cranial hemorrhage.
  2. Patients younger than 18 years.
  3. Patients with acute ischemic stroke due to small vessel disease or vasculitis.
  4. Patients with acute ischemic stroke due to occlusion of vessels of posterior circulation.
  5. Patients who refused to be included in the study.
  6. Patients with contraindications to intracranial stent placement (as total occlusion of artery).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    number of participants with good re-perfusion after successful rescue stenting
    this may help in case selection for best outcomes of the procedure

    Secondary Outcome Measures

    Compare the clinical outcomes of participants with rescue stenting with those who received medical treatment.
    Compare the radio-logical outcomes of participants with rescue stenting with those who received medical treatment.

    Full Information

    First Posted
    July 17, 2021
    Last Updated
    July 28, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04987710
    Brief Title
    Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
    Official Title
    Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    June 30, 2023 (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
    Yes

    5. Study Description

    Brief Summary
    The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.
    Detailed Description
    Mechanical Thrombectomy is the first line therapy in acute ischemic stroke due to large vessel occlusion. Recently, there is an increasing number of patients with failed re perfusion after mechanical thrombectomy, due to preexisting high degree of intracranial stenosis or failed mechanical thrombectomy. This is associated with poor clinical and functional outcome for the patients. The percentage of patients with failed mechanical thrombectomy is as high as 40-45% of all patients with ischemic stroke due to large vessel occlusion. This group is in need for rescue intracranial stenting to achieve re-canalization of the occluded vessel and restore perfusion. The results demonstrated superiority of medical management over stenting with less complications and this had almost put the intracranial stenting to rest for years. The main complication related to rescue stenting are ischemic complications especially thromboembolic events related to thrombus detachment, symptomatic intracerebral hemorrhage and re-stenosis of cerebral arteries after stenting. Recently, the results of the Chinese Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis trial and the Wingspan Stent System Post Market Surveillance Study (WEAVE trial) showed that most of complications are related to peri-procedural techniques. This raise the interest again in the efficacy of intracranial stenting as treatment modality for selected patients. The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    intracranial rescue stenting
    Intervention Description
    use of intracranial rescue stenting as re-perfusion technique after failed thrombectomy
    Primary Outcome Measure Information:
    Title
    number of participants with good re-perfusion after successful rescue stenting
    Description
    this may help in case selection for best outcomes of the procedure
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Compare the clinical outcomes of participants with rescue stenting with those who received medical treatment.
    Time Frame
    12 months
    Title
    Compare the radio-logical outcomes of participants with rescue stenting with those who received medical treatment.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with acute ischemic stroke due to large vessel occlusion as confirmed by CT angiography or Magnetic resonance (MR) angiography. Baseline NIHSS >6. Presenting within the first 6 hours from onset of symptoms. First ever stroke or pre-stroke modified Rankin Score (mRS) ≤1. Exclusion Criteria: Patients with intra cranial hemorrhage. Patients younger than 18 years. Patients with acute ischemic stroke due to small vessel disease or vasculitis. Patients with acute ischemic stroke due to occlusion of vessels of posterior circulation. Patients who refused to be included in the study. Patients with contraindications to intracranial stent placement (as total occlusion of artery).

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    Citation
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