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

Completed

• Conditions: Stroke, Ischemic; Intracranial Atherosclerosis
• Interventions: Diagnostic Test: MR screening

• Registration Number: NCT05631470
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study Start: 2019-06-18
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-11-30
• Status Verified: 2023-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The rate of all-cause stroke and mortality.	3 months

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China