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

Stroke, Ischemic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631470
• Other study ID #: XWFFR-2
• Status: Completed
• Start date: June 18, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Stroke, Ischemic

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	National Key Research and Development Project, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The rate of all-cause stroke and mortality.		3 months