Ischemic StrokeNCT07497152
Application of High-Resolution Magnetic Resonance Vessel Wall Imaging in Endovascular Treatment
An observational study of Ischemic Stroke, run by Shanghai East Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Nov 2025
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective observational study included patients with severe middle cerebral artery (MCA) stenosis who underwent percutaneous transluminal angioplasty and stenting (PTAS)
Who may be able to join
- 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.
Who cannot join
- 1) 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of High-Resolution Magnetic Resonance Vessel Wall Imaging in Endovascular Treatment: A Middle Cerebral Artery (MCA) Stenosis Cohort Study
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.
Read the 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
- Ischemic Stroke
- Keywords
- Middle Cerebral Artery (MCA) Stenosis, high-resolution magnetic resonance vessel wall imaging (HRMRI-VWI), percutaneous transluminal angioplasty and stenting (PTAS)
- Medical subject headings
- Ischemic Stroke, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vessel wall enhanced (EVWE) group | Not described | |
| no-enhanced group (NE) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of recurrent ischemic stroke in 15 months
Measured: 15 months (±1 month) after angioplasty and stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jun 2021
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497152
- Sponsor's protocol ID
- EAST-HRMRI
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of High-Resolution Magnetic Resonance Vessel Wall Imaging in Endovascular Treatment: A Middle Cerebral Artery (MCA) Stenosis Cohort Study
- ClinicalTrials.gov ID
- NCT07497152
- Acronym / sponsor ID
- EAST-HRMRI
- Conditions
- Ischemic Stroke
- Keywords
- Middle Cerebral Artery (MCA) Stenosis, high-resolution magnetic resonance vessel wall imaging (HRMRI-VWI), percutaneous transluminal angioplasty and stenting (PTAS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vessel wall enhanced (EVWE) group | – | – |
| no-enhanced group (NE) | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective observational study included patients with severe middle cerebral artery (MCA) stenosis who underwent percutaneous transluminal angioplasty and stenting (PTAS)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the occurrence of recurrent ischemic stroke in 15 months
Time frame: 15 months (±1 month) after angioplasty and stenting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of recurrent ischemic stroke in 15 months (time frame: 15 months (±1 month) after angioplasty and stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.