NCT07309718

Brief Summary

Intracranial atherosclerotic stenosis (ICAS) carries substantial stroke risk despite optimal medical treatment. Current risk stratification relies primarily on stenosis severity, but novel hemodynamic markers may improve prediction. In this multiple prospective registry study we aim to investigate whether regional hemodynamics, measured by a novel Magnetic resonance imaging-derived Pressure Ratio (MPR) technique, are associated with stroke risk in ICAS.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Dec 2025Mar 2028

Study Start

First participant enrolled

December 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

ICAS - Intracranial AtherosclerosisStroke IschemicHemodynamicPressure ratio

Outcome Measures

Primary Outcomes (1)

  • ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.

    the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.

    12 months

Secondary Outcomes (5)

  • transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year

    12 months

  • TIA related to ischemia in the qualifying artery territory within 1 year

    12 months

  • any stroke/TIA/ death within 1 year

    12 months

  • hemodynamic ischemic stroke in the qualifying artery territory within 1 year

    12 months

  • embolic stroke within in the qualifying artery territory 1 year

    12 months

Study Arms (1)

CASSISS-MPR

Drug: Standardized medical therapy targeting vascular risk factors and stroke prevention

Interventions

Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines

CASSISS-MPR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ICAS involving 50% to 99% stenosis of a major intracranial artery in the anterior circulation, including the internal carotid artery (ICA C6-C7 segment) and the middle cerebral artery M1 (MCA-M1) segment.

You may qualify if:

  • Adults aged 18 to 80 years.
  • Intracranial atherosclerotic stenosis ICAS involving a culprit artery in the anterior circulation.
  • Intracranial arterial stenosis of 50% to 99% as measured by the WASID method using TCD, CTA, MRA, or DSA.
  • Written informed consent obtained from the participant or a legal representative.

You may not qualify if:

  • Non-atherosclerotic intracranial lesions, including moyamoya disease, vasculitis, vascular dissection, autoimmune diseases, or congenital/genetic abnormalities.
  • More than 50% stenosis of the extracranial carotid artery on the ipsilateral side.
  • Large cerebral infarction involving more than one-half of the territory on DWI imaging, or a baseline modified Rankin Scale score ≥3.
  • Contraindications to antiplatelet therapy or statins.
  • Inability to undergo MRI due to metal implants or claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Xuanwu hospital

Beijing, Xicheng District, 100053, China

RECRUITING

MeSH Terms

Conditions

Intracranial ArteriosclerosisIschemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesStroke

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 30, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations