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NCT Number: NCT07497152

Application of High-Resolution Magnetic Resonance Vessel Wall Imaging in Endovascular Treatment

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

About this study

This study is prospective observational study included patients with severe middle cerebral artery (MCA) stenosis who underwent percutaneous transluminal angioplasty and stenting (PTAS). On the basis of the enhancement of stenosis was similar or over than intracranial arterial wall without stenosis, we divided these patients into enhanced group (EVWE) and no-enhanced group (NE). The primary outcome was the occurrence of recurrent ischemic stroke in the territory of the treated MCA 15 months (±1 month) after angioplasty and stenting. The secondary outcomes included: 1) 15 months acute stroke including AIS AND ICH 2) peri-operation acute stroke including AIS AND ICH 3) the degree of in-stent restenosis (ISR) at 3 months(±1 week) and 15 months(±1 month) after the procedure, as measured by digital subtraction angiography (DSA) using the WASID criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1)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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. the occurrence of recurrent ischemic stroke in 15 months

    Time frame: 15 months (±1 month) after angioplasty and stenting

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study title

Application of High-Resolution Magnetic Resonance Vessel Wall Imaging in Endovascular Treatment: A Middle Cerebral Artery (MCA) Stenosis Cohort Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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