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Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

Primary Purpose

Intracranial Atherosclerosis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Percutaneous transluminal angioplasty and stenting
Aspirin plus clopidogrel
Sponsored by
The 476th Hospital of People's Liberation Army
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Atherosclerosis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients aged from 18 to 70 years.
  • Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
  • A length ≤ 15mm of a stenosis in the target vessel and a vessel size >2.5mm.
  • Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
  • CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
  • Patients who understand the purpose of the study and have provided informed consent.

Exclusion Criteria:

  • Not able to receive general anesthesia.
  • Not able to receive angiographic assessment.
  • A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.
  • Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
  • A high risk (leading to a stroke or death) to deliver the stent to the lesion.
  • A previous stent or angioplasty in the target lesion.
  • Progressive neurological signs within 24 hours before enrolment
  • Any haemorrhagic infarct within 14 days before enrolment
  • The presence of a cardiac source of embolus
  • Thrombolytic therapy within 24 hours before enrollment
  • Presence of intraluminal thrombus proximal to or at the target lesion
  • Myocardial infarction within previous 30 days
  • Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus.
  • Known contraindications for aspirin and clopidogrel treatment.
  • An modified Rankin scale≥3.
  • With a childbearing potential or a positive pregnancy test in 1 week before enrolment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    stenting+medical treatment

    Aspirin plus clopidogrel

    Arm Description

    Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)

    Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.

    Outcomes

    Primary Outcome Measures

    Proportion of patients with events of stroke or death

    Secondary Outcome Measures

    the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory
    neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)
    Proportion of patients with adverse events

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    April 4, 2016
    Sponsor
    The 476th Hospital of People's Liberation Army
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02689037
    Brief Title
    Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis
    Official Title
    Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The 476th Hospital of People's Liberation Army

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial. Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS. Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Atherosclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    394 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    stenting+medical treatment
    Arm Type
    Experimental
    Arm Description
    Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
    Arm Title
    Aspirin plus clopidogrel
    Arm Type
    Active Comparator
    Arm Description
    Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous transluminal angioplasty and stenting
    Other Intervention Name(s)
    PTAS
    Intervention Description
    Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin plus clopidogrel
    Other Intervention Name(s)
    Aspirin+clopidogrel
    Intervention Description
    aspirin 100mg daily and clopidogrel 75mg daily for 90 days
    Primary Outcome Measure Information:
    Title
    Proportion of patients with events of stroke or death
    Time Frame
    at 30 days after randomization
    Secondary Outcome Measure Information:
    Title
    the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory
    Time Frame
    30 days and 1 year after randomization
    Title
    neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)
    Time Frame
    30 days and 1 year after randomization
    Title
    Proportion of patients with adverse events
    Time Frame
    30 days and 1 year after randomization

    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: Patients aged from 18 to 70 years. Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery. A length ≤ 15mm of a stenosis in the target vessel and a vessel size >2.5mm. Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting. CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor. Patients who understand the purpose of the study and have provided informed consent. Exclusion Criteria: Not able to receive general anesthesia. Not able to receive angiographic assessment. A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side. Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis. A high risk (leading to a stroke or death) to deliver the stent to the lesion. A previous stent or angioplasty in the target lesion. Progressive neurological signs within 24 hours before enrolment Any haemorrhagic infarct within 14 days before enrolment The presence of a cardiac source of embolus Thrombolytic therapy within 24 hours before enrollment Presence of intraluminal thrombus proximal to or at the target lesion Myocardial infarction within previous 30 days Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus. Known contraindications for aspirin and clopidogrel treatment. An modified Rankin scale≥3. With a childbearing potential or a positive pregnancy test in 1 week before enrolment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiao-Ping Cui, MD
    Phone
    0591-22859529
    Email
    xiaopingcuidr@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hang Lin, MD
    Organizational Affiliation
    Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27852711
    Citation
    Cui XP, Lin M, Mu JS, Ye JX, He WQ, Fu ML, Li H, Fang JY, Shen FF, Lin H. Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial. BMJ Open. 2016 Nov 15;6(11):e012175. doi: 10.1136/bmjopen-2016-012175.
    Results Reference
    derived

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    Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

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