Clinical Trials Directory

Trials / Completed

CompletedNCT07497152

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
74 (actual)
Sponsor
Shanghai East Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Timeline

Start date
2021-06-01
Primary completion
2025-11-30
Completion
2025-11-30
First posted
2026-03-27
Last updated
2026-03-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07497152. Inclusion in this directory is not an endorsement.