Effects of Medical Treatment of ICAS With Hemodynamic Disorders Based on MR-FFR

Last updated: December 25, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Blood Clots

Treatment

Standard Medical Treatment on the basis of anti-platelet therapy

Clinical Study ID

NCT06196398
XWFFR-3
  • Ages 30-80
  • All Genders

Study Summary

This multicenter prospective cohort study aims to compare the difference in the effects of medical treatment within 1 year between the two groups of ICAS patients divided hemodynamically by Magnetic Resonance Fractional Flow Reserve. PC MRA will be applied for FFR measurement. The primary outcome is the composite of ischemic stroke or death related to the qualifying artery territory for 1 year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation.
  2. 50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTAor MRA.
  3. mRS 0-2 points
  4. Informed of the study protocol and objectives.

Exclusion

Exclusion Criteria:

  1. Previous endovascular treatment or surgery for cerebrovascular diseases
  2. Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI
  3. Combined with other neurological diseases, such as aneurysm, arteriovenousmalformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiplesclerosis, epilepsy and intracranial infection.
  4. Pregnancy or in the preparation for pregnancy
  5. Patients who cannot tolerate or do not allow MR screening, including metal implantingand claustrophobia
  6. Contraindication for antiplatelet drugs or statins
  7. Patients with severe dementia or mental disorders, who cannot cooperate withexamination

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Standard Medical Treatment on the basis of anti-platelet therapy
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing
    China

    Active - Recruiting

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