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

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05631470
Collaborator
National Key Research and Development Project, China (Other)
200
Enrollment
1
Location
47.4
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MR screening

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diagnostic Accuracy for Hemodynamical Intracranial Atherosclerotic Diseases (ICAS) of Magnetic-Resonance-based Fractional Flow Reserve (MR-FFR) Comparing With Pressure-wire-based FFR.
Actual Study Start Date :
Jun 18, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Enrolled

Participants with ICAS will be scheduled for both MR screening and pressure-wire-based FFR measurement.

Diagnostic Test: MR screening
This study is to compare the results of MR-FFR with pressure-wired-based FFR measurement.
Other Names:
  • Pressure-wire-based FFR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic accuracy of MR-FFR measurement. [3 days]

      The consistency of the two groups in the interpretation of hemodynamic conditions across the ICAS lesion.

    Secondary Outcome Measures

    1. The rate of all-cause stroke and mortality. [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients aged 18 years or older.

    2. 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).

    3. 50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).

    4. Informed of the study protocol and objectives.

    Exclusion Criteria:

    1. Non-atherosclerotic MCA stenosis

    2. Combined with moderate or severe stenosis of other extracranial and intracranial arteries

    3. Previous endovascular treatment or surgery for cerebrovascular diseases

    4. Large cerebral infarction (more than 1/2 MCA perfusion area)

    5. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.

    6. Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention

    7. Liver and kidney dysfunction, or severe allergy to the contrast agent

    8. Severe coagulation dysfunction

    9. Pregnancy or in the preparation for pregnancy

    10. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia

    11. Patients with severe dementia or mental disorders, who cannot cooperate with examination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xuanwu Hospital, Capital Medical University Beijing Beijing China

    Sponsors and Collaborators

    • Xuanwu Hospital, Beijing
    • National Key Research and Development Project, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xuanwu Hospital, Beijing
    ClinicalTrials.gov Identifier:
    NCT05631470
    Other Study ID Numbers:
    • XWFFR-2
    First Posted:
    Nov 30, 2022
    Last Update Posted:
    Jan 11, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xuanwu Hospital, Beijing
    Intracranial atherosclerotic diseases
    Fractional Flow Reserve
    Additional relevant MeSH terms:
    Ischemic Stroke
    Intracranial Arteriosclerosis
    Atherosclerosis

    Study Results

    No Results Posted as of Jan 11, 2023