NCT07497152

Brief Summary

Intracranial atherosclerotic disease (ICAD) is one of the most important causes of ischemic stroke and is also associated with some recurrent stroke. Safety and effective treatment of ICAD is an important precondition to improve the prognosis of patients. The current therapy for middle cerebral artery stenosis was medication and vascular intervention. Traditional assessment methods for intracranial artery, such as magnetic resonance angiography (MRA), computed tomography angiography (CTA) and digital subtraction angiography (DSA), could mainly assess the stenosis degree of the intracranial artery. While, the high-resolution magnetic vessel wall examination has been a pivotal image examination for diagnosing intracranial arterial disease and it provides a unique insight into the atherosclerotic lesions of vessel wall. Therefore, the study aims to explore the association between HRMRI-VWI enhancement for stroke recurrence in ICAS patients treated with MCA angioplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

Middle Cerebral Artery (MCA) Stenosishigh-resolution magnetic resonance vessel wall imaging (HRMRI-VWI)percutaneous transluminal angioplasty and stenting (PTAS)

Outcome Measures

Primary Outcomes (1)

  • the occurrence of recurrent ischemic stroke in 15 months

    15 months (±1 month) after angioplasty and stenting

Study Arms (2)

vessel wall enhanced (EVWE) group

no-enhanced group (NE)

Eligibility Criteria

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

This prospective observational study included patients with severe middle cerebral artery (MCA) stenosis who underwent percutaneous transluminal angioplasty and stenting (PTAS)

You may qualify if:

  • )patients aged between 18 and 80 years; 2) ischemic stroke or transient ischemic attack (TIA) involving the target artery within the preceding 90 days those presenting with symptomatic MCA stenosis of 70% or greater, as confirmed by digital subtraction angiography (DSA) based on the WASID criteria; 3) Treating of routine antiplatelet and statin treatment and risk factor management, while would accept cerebral artery angioplasty treatment ; 4) MRS score less than 2 points before angioplasty treatment 5) provided written informed consent.

You may not qualify if:

  • \) bilateral MCA stenosis or non-atherosclerotic vasculopathies such as moyamoya disease and vasculitis; 2) cardioembolic stroke or other defined etiologies according to the TOAST classification; 3) serious systemic comorbidities (e.g., heart failure, renal insufficiency, or malignancy) that could affect prognosis or procedural safety; 4) contraindications to MRI or contrast agents, including metal implants or severe allergic reactions and poor MRI imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, Shanghai, China

Location

MeSH Terms

Conditions

Ischemic StrokeConstriction, Pathologic

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

June 1, 2021

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

March 27, 2026

Record last verified: 2026-02

Locations