Diagnostic Accuracy for Hemodynamically ICAS of MR-FFR Comparing With Pressure-wire-based FFR.

Study Overview
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Brief Summary
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The aim of this study was to determine the diagnostic accuracy of MR-FFR to detect functionally significant ICAS comparing with pressure-wire-based FFR.

Detailed Description
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This study will perform a head-to-head comparison between MR-FFR and pressure-wire-based FFR in patients with ICAS. Pressure-wire-based FFR will be used as the gold standard for intravascular pressure gradient measurement. The efficacy and safety of non-invasive FFR will be assessed in this study.

Official Title
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Diagnostic Accuracy for Hemodynamical Intracranial Atherosclerotic Diseases (ICAS) of Magnetic-Resonance-based Fractional Flow Reserve (MR-FFR) Comparing With Pressure-wire-based FFR.

Conditions
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Stroke, Ischemic, Intracranial Atherosclerosis

Intervention / Treatment
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* Diagnostic Test: MR screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older. Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (intracranial internal carotid artery and their major branches). 50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA). Informed of the study protocol and objectives. Exclusion Criteria: Non-atherosclerotic MCA stenosis Combined with moderate or severe stenosis of other extracranial and intracranial arteries Previous endovascular treatment or surgery for cerebrovascular diseases Large cerebral infarction (more than 1/2 MCA perfusion area) Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection. Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention Liver and kidney dysfunction, or severe allergy to the contrast agent Severe coagulation dysfunction Pregnancy or in the preparation for pregnancy Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia Patients with severe dementia or mental disorders, who cannot cooperate with examination

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled<br>Participants with ICAS will be scheduled for both MR screening and pressure-wire-based FFR measurement. | Diagnostic Test: MR screening<br>* This study is to compare the results of MR-FFR with pressure-wired-based FFR measurement.<br>* Other names: Pressure-wire-based FFR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of MR-FFR measurement. | The consistency of the two groups in the interpretation of hemodynamic conditions across the ICAS lesion. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of all-cause stroke and mortality. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial atherosclerotic diseases, Fractional Flow Reserve