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IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

Primary Purpose

ICAS - Intracranial Atherosclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stenting plus medical therapy
Medical therapy alone
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ICAS - Intracranial Atherosclerosis focused on measuring ICAS, Cerebral Arteriosclerosis

Eligibility Criteria

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

Inclusion Criteria: Age ≥30 and ≤80 years old. Symptomatic intracranial atherosclerotic stenosis: Transient ischemic attack (TIA) or stroke related to 70%-99% stenosis in the major intracranial arteries (intracranial segment of the internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, and basilar artery) within the past 3 months. Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in the trial (WASID criteria). Patients with ischemic stroke should be performed with stenting beyond a duration of 2 weeks from the latest ischemic symptom onset, patients with TIA have no time restriction. Pre-enrollment modified Rankin Scale (mRS) score ≤2. Target vessel reference diameter must be measured to be 2 mm to 4.5 mm, target area of stenosis is less than or equal to 14mm in length. Patients required to meet at least with one atherosclerotic risk factors, including hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, smoking history, and atherosclerosis in other arterial vessels. Negative pregnancy test in a female who has had any menses in the last 18 months. Patient is willing and able to return for all follow-up visits required by the protocol. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent. Exclusion Criteria: Intracranial arterial stenosis not caused by atherosclerotic lesions, such as arterial dissection, moya-moya disease, vasculitic disease, viral vascular lesions (e.g., herpes zoster, varicella), neurosyphilis, other intracranial infections, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign central nervous system vascular diseases, postpartum angiopathy, suspected vasospastic process, suspected recanalized embolus, etc. Any conditions that precludes proper angiographic assessment. Preoperative MRI indicating only lacunar infarction in the target lesion territory. History of subarachnoid hemorrhage, subdural or epidural hematoma within 30 days prior to enrollment, or untreated chronic subdural hematoma thickness≥5mm, or history of primary intracerebral hemorrhage. At risk of hemorrhagic transformation during the procedure (CT or MRI showing infarct area diameter >5 cm); hemorrhagic transformation of an ischemic stroke within the past 15 days (detected by CT). Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which lesion is symptomatic (for example, if patient has pon, midbrain, temporal and occipital symptoms). Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion Severe vascular tortuosity, severe calcification, or other factors that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement. Presence of intraluminal thrombus proximal to or at the target lesion. Any aneurysm proximal to or distal to intracranial stenotic artery. Intracranial tumors or any intracranial vascular malformations. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc. Myocardial infarction within previous 30 days. Suspected severe allergy or contraindication to vascular interventional-related drugs or devices, such as aspirin, clopidogrel, general anesthesia agents, heparin, contrast agents, nitinol alloy, etc. Active bleeding diathesis or coagulopathy, active gastrointestinal ulcer, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count <100,000, hematocrit <30, INR >1.5, dysfunctions of the blood coagulation system. uncontrolled severe hypertension (systolic BP>180mm Hg or diastolic BP>110mm Hg) Severe comorbidities or unstable conditions, such as severe heart failure, respiratory failure, or renal failure (serum creatinine>264μmol/L, unless on dialysis), severe liver dysfunction (ALT or ALT >3 times normal), malignant tumors. Major surgery performed within 30 days prior to enrollment or planned inpatient surgery within 90 days after enrollment. Pregnancy or intent to become pregnant during the trial period. Currently participating in another clinical trial. Life expectancy less than 3 years Patients unable to complete follow-up due to cognitive impairment, emotional disorders, or mental illness.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    Control group

    Arm Description

    Stenting plus medical therapy

    Medical therapy alone

    Outcomes

    Primary Outcome Measures

    Stroke or death
    Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.

    Secondary Outcome Measures

    Ischemic stroke in the target vessel territory
    Ischemic stroke in the target vessel territory
    Ischemic stroke in non-target vessel territory
    Ischemic stroke in non-target vessel territory
    Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
    Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
    Any cause of death
    Any cause of death
    mRS score
    Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.
    National Institutes of Health Stroke Scale (NIHSS) score
    Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.
    Barthel Index
    An ordinal scale which measures a person's ability to complete activities of daily living. The value range 0-100: higher scores mean a better outcome.

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 1, 2023
    Sponsor
    Changhai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05974033
    Brief Title
    IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)
    Official Title
    IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changhai Hospital

    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
    A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.
    Detailed Description
    The main objective of this study is to investigate the impact of angiography-derived fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether stenting plus medical therapy, compared to medical therapy alone, can benefit patients selected through Angio-FF screening. For Group A, patients with significant stenosis and hemodynamic impairment identified through Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled in RCT trial, with a planned enrollment of 336 subjects. For Group B, patients with significant stenosis but without hemodynamic impairment identified through Angio-FF (>0.7) screening will be included in the registry cohort, with a planned enrollment of 200 subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ICAS - Intracranial Atherosclerosis
    Keywords
    ICAS, Cerebral Arteriosclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    536 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Stenting plus medical therapy
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Medical therapy alone
    Intervention Type
    Combination Product
    Intervention Name(s)
    Stenting plus medical therapy
    Intervention Description
    Patients randomized to intervention group received the percutaneous transluminal balloon angioplasty with stenting within 5 days after randomization, and loading dose of aspirin and clopidogrel was allowed. Received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after procedure.
    Intervention Type
    Drug
    Intervention Name(s)
    Medical therapy alone
    Intervention Description
    Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.
    Primary Outcome Measure Information:
    Title
    Stroke or death
    Description
    Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.
    Time Frame
    Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year.
    Secondary Outcome Measure Information:
    Title
    Ischemic stroke in the target vessel territory
    Description
    Ischemic stroke in the target vessel territory
    Time Frame
    Within 1-3 years after enrollment
    Title
    Ischemic stroke in non-target vessel territory
    Description
    Ischemic stroke in non-target vessel territory
    Time Frame
    Within 30 days to 1 year, and within 1-3 years after enrollment
    Title
    Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
    Description
    Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
    Time Frame
    Within 30 days to 3 years after enrollment
    Title
    Any cause of death
    Description
    Any cause of death
    Time Frame
    Within 30 days to 3 years after enrollment
    Title
    mRS score
    Description
    Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.
    Time Frame
    At 1 year, 2 years, and 3 years after enrollment
    Title
    National Institutes of Health Stroke Scale (NIHSS) score
    Description
    Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.
    Time Frame
    At 1 year, 2 years, and 3 years after enrollment
    Title
    Barthel Index
    Description
    An ordinal scale which measures a person's ability to complete activities of daily living. The value range 0-100: higher scores mean a better outcome.
    Time Frame
    At 1 year, 2 years, and 3 years after enrollment

    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: Age ≥30 and ≤80 years old. Symptomatic intracranial atherosclerotic stenosis: Transient ischemic attack (TIA) or stroke related to 70%-99% stenosis in the major intracranial arteries (intracranial segment of the internal carotid artery, M1 segment of the middle cerebral artery, V4 segment of the vertebral artery, and basilar artery) within the past 3 months. Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in the trial (WASID criteria). Patients with ischemic stroke should be performed with stenting beyond a duration of 2 weeks from the latest ischemic symptom onset, patients with TIA have no time restriction. Pre-enrollment modified Rankin Scale (mRS) score ≤2. Target vessel reference diameter must be measured to be 2 mm to 4.5 mm, target area of stenosis is less than or equal to 14mm in length. Patients required to meet at least with one atherosclerotic risk factors, including hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease, obesity, smoking history, and atherosclerosis in other arterial vessels. Negative pregnancy test in a female who has had any menses in the last 18 months. Patient is willing and able to return for all follow-up visits required by the protocol. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent. Exclusion Criteria: Intracranial arterial stenosis not caused by atherosclerotic lesions, such as arterial dissection, moya-moya disease, vasculitic disease, viral vascular lesions (e.g., herpes zoster, varicella), neurosyphilis, other intracranial infections, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign central nervous system vascular diseases, postpartum angiopathy, suspected vasospastic process, suspected recanalized embolus, etc. Any conditions that precludes proper angiographic assessment. Preoperative MRI indicating only lacunar infarction in the target lesion territory. History of subarachnoid hemorrhage, subdural or epidural hematoma within 30 days prior to enrollment, or untreated chronic subdural hematoma thickness≥5mm, or history of primary intracerebral hemorrhage. At risk of hemorrhagic transformation during the procedure (CT or MRI showing infarct area diameter >5 cm); hemorrhagic transformation of an ischemic stroke within the past 15 days (detected by CT). Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which lesion is symptomatic (for example, if patient has pon, midbrain, temporal and occipital symptoms). Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion Severe vascular tortuosity, severe calcification, or other factors that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement. Presence of intraluminal thrombus proximal to or at the target lesion. Any aneurysm proximal to or distal to intracranial stenotic artery. Intracranial tumors or any intracranial vascular malformations. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc. Myocardial infarction within previous 30 days. Suspected severe allergy or contraindication to vascular interventional-related drugs or devices, such as aspirin, clopidogrel, general anesthesia agents, heparin, contrast agents, nitinol alloy, etc. Active bleeding diathesis or coagulopathy, active gastrointestinal ulcer, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count <100,000, hematocrit <30, INR >1.5, dysfunctions of the blood coagulation system. uncontrolled severe hypertension (systolic BP>180mm Hg or diastolic BP>110mm Hg) Severe comorbidities or unstable conditions, such as severe heart failure, respiratory failure, or renal failure (serum creatinine>264μmol/L, unless on dialysis), severe liver dysfunction (ALT or ALT >3 times normal), malignant tumors. Major surgery performed within 30 days prior to enrollment or planned inpatient surgery within 90 days after enrollment. Pregnancy or intent to become pregnant during the trial period. Currently participating in another clinical trial. Life expectancy less than 3 years Patients unable to complete follow-up due to cognitive impairment, emotional disorders, or mental illness.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pengfei Yang, M.D.
    Phone
    86-21-31161784
    Email
    15921196312@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianimin Liu, M.D.
    Organizational Affiliation
    Changhai Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
    IPD Sharing Time Frame
    Data sharing will be available from 12 months after the publication of the main results.
    IPD Sharing Access Criteria
    The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses
    IPD Sharing URL
    http://www.ocin.org.cn/about

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    IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

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