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

NCT05631470 | Completed

• 1 other identifier: XWFFR-2
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Intracranial Atherosclerosis

Keywords

Intracranial atherosclerotic diseases; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The rate of all-cause stroke and mortality.

  3 months

Study Arms (1)

Enrolled

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

Diagnostic Test: MR screening

Interventions

MR screening DIAGNOSTIC_TEST

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

Also known as: Pressure-wire-based FFR

Enrolled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic ICAS resorting to endovascular therapy in our center were recruited consecutively.

You may qualify if:

• 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).
• % 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: June 18, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-01

Locations

CN (1)