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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05631470

Enrollment

Registered

2022-11-30

Start date

2019-06-18

Completion date

2023-03-01

Last updated

2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Atherosclerosis, Stroke, Ischemic

Keywords

Intracranial atherosclerotic diseases, Fractional Flow Reserve

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.

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.

Interventions

DIAGNOSTIC_TESTMR screening

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
The rate of all-cause stroke and mortality.	3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026