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Completed

NCT Number: NCT05631470

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR screening

Diagnostic Test

This study is to compare the results of MR-FFR with pressure-wired-based FFR measurement.

Other names: Pressure-wire-based FFR

Primary outcomes

  1. Diagnostic accuracy of MR-FFR measurement.

    Time frame: 3 days

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

Secondary outcomes

  1. The rate of all-cause stroke and mortality.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • National Key Research and Development Project, China

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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