xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974033</url>
    </required_header>
    <id_info>
      <org_study_id>ICAS-MT</org_study_id>
      <nct_id>NCT05974033</nct_id>
    </id_info>
    <brief_title>IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)</brief_title>
    <official_title>IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changhai Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical&#xD;
        trial with an &quot;all comers&quot; design.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main objective of this study is to investigate the impact of angiography-derived&#xD;
        fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with&#xD;
        symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether&#xD;
        stenting plus medical therapy, compared to medical therapy alone, can benefit patients&#xD;
        selected through Angio-FF screening.&#xD;
  &#xD;
        For Group A, patients with significant stenosis and hemodynamic impairment identified through&#xD;
        Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled&#xD;
        in RCT trial, with a planned enrollment of 336 subjects.&#xD;
  &#xD;
        For Group B, patients with significant stenosis but without hemodynamic impairment identified&#xD;
        through Angio-FF (&gt;0.7) screening will be included in the registry cohort, with a planned&#xD;
        enrollment of 200 subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Stroke or death</measure>
      <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.</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ischemic stroke in the target vessel territory</measure>
      <time_frame>Within 1-3 years after enrollment</time_frame>
      <description>Ischemic stroke in the target vessel territory</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ischemic stroke in non-target vessel territory</measure>
      <time_frame>Within 30 days to 1 year, and within 1-3 years after enrollment</time_frame>
      <description>Ischemic stroke in non-target vessel territory</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage</measure>
      <time_frame>Within 30 days to 3 years after enrollment</time_frame>
      <description>Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any cause of death</measure>
      <time_frame>Within 30 days to 3 years after enrollment</time_frame>
      <description>Any cause of death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mRS score</measure>
      <time_frame>At 1 year, 2 years, and 3 years after enrollment</time_frame>
      <description>Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Institutes of Health Stroke Scale (NIHSS) score</measure>
      <time_frame>At 1 year, 2 years, and 3 years after enrollment</time_frame>
      <description>Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barthel Index</measure>
      <time_frame>At 1 year, 2 years, and 3 years after enrollment</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">536</enrollment>
    <condition>ICAS - Intracranial Atherosclerosis</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Stenting plus medical therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Medical therapy alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Stenting plus medical therapy</intervention_name>
      <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.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Medical therapy alone</intervention_name>
      <description>Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥30 and ≤80 years old.&#xD;
  &#xD;
            2. Symptomatic intracranial atherosclerotic stenosis: Transient ischemic attack (TIA) or&#xD;
               stroke related to 70%-99% stenosis in the major intracranial arteries (intracranial&#xD;
               segment of the internal carotid artery, M1 segment of the middle cerebral artery, V4&#xD;
               segment of the vertebral artery, and basilar artery) within the past 3 months.&#xD;
  &#xD;
            3. Only one target vessel with 70-99% stenosis confirmed by angiography for enrollment in&#xD;
               the trial (WASID criteria).&#xD;
  &#xD;
            4. Patients with ischemic stroke should be performed with stenting beyond a duration of 2&#xD;
               weeks from the latest ischemic symptom onset, patients with TIA have no time&#xD;
               restriction.&#xD;
  &#xD;
            5. Pre-enrollment modified Rankin Scale (mRS) score ≤2.&#xD;
  &#xD;
            6. Target vessel reference diameter must be measured to be 2 mm to 4.5 mm, target area of&#xD;
               stenosis is less than or equal to 14mm in length.&#xD;
  &#xD;
            7. Patients required to meet at least with one atherosclerotic risk factors, including&#xD;
               hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia, coronary heart disease,&#xD;
               obesity, smoking history, and atherosclerosis in other arterial vessels.&#xD;
  &#xD;
            8. Negative pregnancy test in a female who has had any menses in the last 18 months.&#xD;
  &#xD;
            9. Patient is willing and able to return for all follow-up visits required by the&#xD;
               protocol.&#xD;
  &#xD;
           10. Patient understands the purpose and requirements of the study, can make him/herself&#xD;
               understood, and has provided informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Intracranial arterial stenosis not caused by atherosclerotic lesions, such as arterial&#xD;
               dissection, moya-moya disease, vasculitic disease, viral vascular lesions (e.g.,&#xD;
               herpes zoster, varicella), neurosyphilis, other intracranial infections,&#xD;
               radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease,&#xD;
               neurofibromatosis, benign central nervous system vascular diseases, postpartum&#xD;
               angiopathy, suspected vasospastic process, suspected recanalized embolus, etc.&#xD;
  &#xD;
            2. Any conditions that precludes proper angiographic assessment.&#xD;
  &#xD;
            3. Preoperative MRI indicating only lacunar infarction in the target lesion territory.&#xD;
  &#xD;
            4. History of subarachnoid hemorrhage, subdural or epidural hematoma within 30 days prior&#xD;
               to enrollment, or untreated chronic subdural hematoma thickness≥5mm, or history of&#xD;
               primary intracerebral hemorrhage.&#xD;
  &#xD;
            5. At risk of hemorrhagic transformation during the procedure (CT or MRI showing infarct&#xD;
               area diameter &gt;5 cm); hemorrhagic transformation of an ischemic stroke within the past&#xD;
               15 days (detected by CT).&#xD;
  &#xD;
            6. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal&#xD;
               or distal to the target intracranial lesion&#xD;
  &#xD;
            7. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about&#xD;
               which lesion is symptomatic (for example, if patient has pon, midbrain, temporal and&#xD;
               occipital symptoms).&#xD;
  &#xD;
            8. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral&#xD;
               artery) or intracranial artery within 30 days prior to expected enrollment date.&#xD;
  &#xD;
            9. Previous treatment of target lesion with a stent, angioplasty, or other mechanical&#xD;
               device, or plan to perform staged angioplasty followed by stenting of target lesion&#xD;
  &#xD;
           10. Severe vascular tortuosity, severe calcification, or other factors that would preclude&#xD;
               the safe introduction of a guiding catheter, guiding sheath or stent placement.&#xD;
  &#xD;
           11. Presence of intraluminal thrombus proximal to or at the target lesion.&#xD;
  &#xD;
           12. Any aneurysm proximal to or distal to intracranial stenotic artery.&#xD;
  &#xD;
           13. Intracranial tumors or any intracranial vascular malformations.&#xD;
  &#xD;
           14. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular&#xD;
               thrombus, heart valve replacement, atrial septal defect, ventricular septal defect,&#xD;
               atrial myxoma, etc.&#xD;
  &#xD;
           15. Myocardial infarction within previous 30 days.&#xD;
  &#xD;
           16. Suspected severe allergy or contraindication to vascular interventional-related drugs&#xD;
               or devices, such as aspirin, clopidogrel, general anesthesia agents, heparin, contrast&#xD;
               agents, nitinol alloy, etc.&#xD;
  &#xD;
           17. Active bleeding diathesis or coagulopathy, active gastrointestinal ulcer, major&#xD;
               systemic hemorrhage within 30 days, active bleeding diathesis, platelets count&#xD;
               &lt;100,000, hematocrit &lt;30, INR &gt;1.5, dysfunctions of the blood coagulation system.&#xD;
  &#xD;
           18. uncontrolled severe hypertension (systolic BP&gt;180mm Hg or diastolic BP&gt;110mm Hg)&#xD;
  &#xD;
           19. Severe comorbidities or unstable conditions, such as severe heart failure, respiratory&#xD;
               failure, or renal failure (serum creatinine&gt;264μmol/L, unless on dialysis), severe&#xD;
               liver dysfunction (ALT or ALT &gt;3 times normal), malignant tumors.&#xD;
  &#xD;
           20. Major surgery performed within 30 days prior to enrollment or planned inpatient&#xD;
               surgery within 90 days after enrollment.&#xD;
  &#xD;
           21. Pregnancy or intent to become pregnant during the trial period.&#xD;
  &#xD;
           22. Currently participating in another clinical trial.&#xD;
  &#xD;
           23. Life expectancy less than 3 years&#xD;
  &#xD;
           24. Patients unable to complete follow-up due to cognitive impairment, emotional&#xD;
               disorders, or mental illness.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jianimin Liu, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Changhai Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pengfei Yang, M.D.</last_name>
      <phone>86-21-31161784</phone>
      <email>15921196312@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ICAS</keyword>
    <keyword>Cerebral Arteriosclerosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intracranial Arteriosclerosis</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data sharing will be available from 12 months after the publication of the main results.</ipd_time_frame>
      <ipd_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.&#xD;
  The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.&#xD;
  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.&#xD;
  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.&#xD;
  The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses</ipd_access_criteria>
      <ipd_url>http://www.ocin.org.cn/about</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974033
  org study id: ICAS-MT
  nct id: NCT05974033
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical
        trial with an "all comers" design.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Stroke or death
  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.
  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.
  measure: Ischemic stroke in the target vessel territory
  time frame: Within 1-3 years after enrollment
  description: Ischemic stroke in the target vessel territory
  measure: Ischemic stroke in non-target vessel territory
  time frame: Within 30 days to 1 year, and within 1-3 years after enrollment
  description: Ischemic stroke in non-target vessel territory
  measure: Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
  time frame: Within 30 days to 3 years after enrollment
  description: Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage
  measure: Any cause of death
  time frame: Within 30 days to 3 years after enrollment
  description: Any cause of death
  measure: mRS score
  time frame: At 1 year, 2 years, and 3 years after enrollment
  description: Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome.
  measure: National Institutes of Health Stroke Scale (NIHSS) score
  time frame: At 1 year, 2 years, and 3 years after enrollment
  description: Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome.
  measure: Barthel Index
  time frame: At 1 year, 2 years, and 3 years after enrollment
  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.
  arm group label: Intervention group
  arm group type: Experimental
  description: Stenting plus medical therapy
  arm group label: Control group
  arm group type: Active Comparator
  description: Medical therapy alone
  intervention type: Combination Product
  intervention name: Stenting plus medical therapy
  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.
  arm group label: Intervention group
  intervention type: Drug
  intervention name: Medical therapy alone
  description: Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jianimin Liu, M.D.
  role: Principal Investigator
  affiliation: Changhai Hospital
  last name: Pengfei Yang, M.D.
  phone: 86-21-31161784
  email: 15921196312@163.com
  responsible party type: Sponsor
  mesh term: Intracranial Arteriosclerosis
  mesh term: Atherosclerosis
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data sharing will be available from 12 months after the publication of the main results.
  ipd 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 url: http://www.ocin.org.cn/about