Acute Ischemic StrokeNCT07456228
Emergency Stroke Unit With NeuAngio-CT (ESU-ACT)
An observational study of Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Rationale: Acute ischemic stroke caused by large-vessel occlusion (LVO) requires rapid recanalization to minimize neurological damage, as shorter onset-to-reperfusion times are strongly associated with better clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Mar 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It includes patients aged ≥18 years with a RACE score ≥4, a pre-stroke mRS score ≤1, and suspected intracranial LVO within 6 hours of onset. Hospitals in the exposure group utilize an Emergency Stroke Unit equipped with a sliding NeuAngio-CT/DSA hybrid suite, while control hospitals follow the conventional imaging workflow.
Who may be able to join
- Age ≥ 18 years;
- Clinically diagnosed with acute ischemic stroke;
- RACE score ≥ 4 points upon hospital arrival;
- Time from symptom onset/last known normal to hospital arrival ≤ 6 hours;
- Pre-stroke mRS score 0-1;
- Informed consent signed by the patient or their legal representative.
Who cannot join
- Hemorrhagic stroke diagnosed by cranial CT or MRI during this current episode;
- Uncontrolled hypertension with medication (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg) (Note: Patients may be included if blood pressure can be successfully reduced and maintained at an acceptable level with medication);
- Known hereditary or acquired bleeding tendency, such as coagulation factor deficiency, or INR > 3.0 or PT > 3 times the normal range after anticoagulant therapy (Patients without a history of coagulation dysfunction or suspected coagulation dysfunction do not need to wait for laboratory results of INR or prothrombin time before enrollment);
- Received heparin, low-molecular-weight heparin (e.g., dalteparin sodium), or thrombin inhibitors (e.g., bivalirudin, argatroban) within 24 hours with a history of coagulation disorders;
- Baseline laboratory values: blood glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L), hemoglobin count < 7 mmol/l (11.28 g/dl); platelet count < 50,000/μl;
- Patients with renal failure, defined as serum creatinine > 3.0 mg/dl (264 μmol/l) (Note: Patients undergoing dialysis can be included regardless of serum creatinine level);
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- Cerebral embolism caused by septic emboli or bacterial endocarditis;
- History of stroke within the past 3 months;
- Seizure at stroke onset leading to diagnostic confusion and difficulty in accurate baseline RACE assessment;
- History of previous neuropsychiatric disorders that make accurate neurological function assessment difficult, such as dementia patients taking cholinesterase inhibitors;
- Diagnosis of cerebral vasculitis, brain tumor, or traumatic brain injury within the past 3 months;
- Major organ surgery or biopsy within 30 days;
- Active bleeding or recent bleeding within 30 days;
- History of previous intracranial stent implantation;
- History of severe contrast agent allergy (non-rash allergy);
- Patients with other contraindications to reperfusion therapy or who refuse reperfusion therapy;
- Life expectancy less than 180 days;
- Lactating women or women with positive pregnancy test on admission;
- Patients who refuse or cannot cooperate with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital
Beijing
Xuewei Xie, Dr., 59978555, xueweixie@163.com
About this study
Official title: Effect of Emergency Stroke Unit With NeuAngio-CT Direct for Acute Ischemic Stroke and Suspected Intracranial Large Vessel Occlusion (ESU-ACT)
Rationale: Acute ischemic stroke caused by large-vessel occlusion (LVO) requires rapid recanalization to minimize neurological damage, as shorter onset-to-reperfusion times are strongly associated with better clinical outcomes. Conventional management workflows, which involve separate non-contrast CT or multimodal imaging assessments prior to transfer to the angiography suite, often introduce significant delays. The implementation of a "one-stop" management model using a hybrid sliding-gantry CT/DSA suite allows for immediate diagnosis and subsequent intervention in a single clinical environment, potentially streamlining the transition to treatment. Therefore, the aim of this study is to demonstrate the superiority of the one-stop hybrid suite workflow compared to standard imaging-first management in improving functional outcomes for patients with suspected LVO presenting within 6 hours of symptom onset.
Methods and Design: This study is a prospective, multicenter, matched cluster, open-label, blinded endpoint non-randomized cohort. It includes patients aged ≥18 years with a RACE score ≥4, a pre-stroke mRS score ≤1, and suspected intracranial LVO within 6 hours of onset. Hospitals in the exposure group utilize an Emergency Stroke Unit equipped with a sliding NeuAngio-CT/DSA hybrid suite, while control hospitals follow the conventional imaging workflow.
Study Outcomes: The primary outcome is the proportion of patients achieving functional independence at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2. The primary safety outcome is the proportion of patients with all-cause mortality at 7 days or at the time of hospital discharge.
Read the detailed description
This study employs a multicenter, matched-cluster controlled design wherein 5 to 10 hospitals equipped with Neusoft Medical's domestic sliding-gantry Angio-CT/Digital Subtraction Angiography (ACT/DSA) system, and staffed by personnel who have completed standardized operational training, will be selected as the Exposure Group, while a corresponding 5 to 10 matched hospitals lacking this integrated system will serve as the Control Group. In the Exposure Group, the protocol dictates an optimized direct-to-angiography suite workflow; upon arrival, patients undergo immediate neurological evaluation utilizing the Rapid Arterial oCclusion Evaluation (RACE) scale and stat laboratory testing before being transferred directly to the angio suite. Intra-suite imaging is then acquired via the sliding-gantry system to perform non-contrast computed tomography (NCCT) and CT angiography (CTA). If a large vessel occlusion (LVO) is confirmed-specifically involving the M1/M2, P1, A1, or basilar artery (BA) segments-endovascular therapy (EVT), encompassing mechanical thrombectomy, balloon angioplasty, and/or stenting, is initiated immediately on the same table. For patients without an identified LVO, intravenous thrombolysis (IVT) is administered in situ if clinical eligibility is met. Conversely, patients in the Control Group will adhere to standard-of-care diagnostic pathways, undergoing initial cross-sectional neuroimaging (NCCT/CTA or MRI/MRA) in a conventional Radiology Department, where IVT is administered in accordance with current guidelines; if an LVO is radiologically confirmed during this standard workflow, patients are subsequently transferred to a separate angiography suite to undergo EVT.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Large Vessel Occlusion, Sliding CT/DSA, One-stop Management, Mechanical Thrombectomy, Emergency Stroke Care
- Medical subject headings
- Ischemic Stroke
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 |
|---|---|---|
| Exposure: one-stop workflow with hybrid sliding NeuAngio-CT/DSA system | After patients arrive at the emergency room, they undergo neurological function assessments (RACE) and routine laboratory tests; eligible patients are then treated according to the one-stop workflow with hybrid sliding NeuAngio-CT/DSA system. | |
| Control: conventional workflow with CT and DSA | After patients arrive at the emergency room, they undergo neurological function assessments (RACE, NIHSS, mRS scores) and routine laboratory tests; eligible patients are then treated according to the conventional workflow with CT and DSA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mRS score 0-2 at 90 days
Scores on the modified Rankin scale (mRS) range from 0 (no neurologic deficit) to 6 (death).
Measured: at 90 days
Secondary outcomes (12)
Proportion of patients with mRS score 0-3 at 90 days
Scores on the modified Rankin scale (mRS) range from 0 (no neurologic deficit) to 6 (death).
Measured: at 90 days
Ordinal (shift) analysis of mRS at 90 days
Scores on the modified Rankin scale (mRS) range from 0 (no neurologic deficit) to 6 (death).
Measured: at 90 days
Length of hospital stay
Measured: From date of enrollment until the date of discharge, assessed up to 3 months
Hospitalization cost
Measured: From date of enrollment until the date of discharge, assessed up to 3 months
Incidence of neurological deterioration within 24 hours after enrollment
Measured: within 24 hours after enrollment
Incidence of neurological deterioration at 7 days/discharge;
neurological deterioration is defined as an increase in NIHSS score of ≥4 points from baseline. Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurological impairment and worse clinical outcomes.
Measured: at 7 days/discharge
Proportion of patients with "early efficacy (NIHSS score decrease ≥10 points, or NIHSS score 0-1)" at 7 days of hospitalization/discharge
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurological impairment and worse clinical outcomes.
Measured: at 7 days or at discharge
Change in infarct volume at 24 hours (±3 hours) (median difference), assessed by central laboratory using MR T2/Flair or CT (evaluated in patients who received endovascular therapy)
Measured: at 24 hours (±3 hours)
Proportion of patients with mTICI > 2b (evaluated in patients who received endovascular therapy)
Measured: immediately after the intervention
Median DPT time measurement (door-to-arterial puncture time) (evaluated in patients who received endovascular therapy)
Measured: door-to-arterial puncture time，recorded immediately after the intervention
Median DRT time measurement (door-to-reperfusion time) (evaluated in patients who received endovascular therapy)
Measured: door-to-reperfusion time，recorded immediately after the intervention
Median DNT time measurement (door-to-needle time) (evaluated in patients who received IVT)
Measured: door-to-needle time，recorded immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Zeguang Ren, Dr., Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456228
- Sponsor's protocol ID
- KY2025-215-02
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Emergency Stroke Unit With NeuAngio-CT Direct for Acute Ischemic Stroke and Suspected Intracranial Large Vessel Occlusion (ESU-ACT)
- ClinicalTrials.gov ID
- NCT07456228
- Acronym / sponsor ID
- KY2025-215-02
- Conditions
- Acute Ischemic Stroke
- Keywords
- Large Vessel Occlusion, Sliding CT/DSA, One-stop Management, Mechanical Thrombectomy, Emergency Stroke Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 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.
Rationale: Acute ischemic stroke caused by large-vessel occlusion (LVO) requires rapid recanalization to minimize neurological damage, as shorter onset-to-reperfusion times are strongly associated with better clinical outcomes. Conventional management workflows, which involve separate non-contrast CT or multimodal imaging assessments prior to transfer to the angiography suite, often introduce significant delays. The implementation of a "one-stop" management model using a hybrid sliding-gantry CT/DSA suite allows for immediate diagnosis and subsequent intervention in a single clinical environment, potentially streamlining the transition to treatment. Therefore, the aim of this study is to demonstrate the superiority of the one-stop hybrid suite workflow compared to standard imaging-first management in improving functional outcomes for patients with suspected LVO presenting within 6 hours of symptom onset.
Methods and Design: This study is a prospective, multicenter, matched cluster, open-label, blinded endpoint non-randomized cohort. It includes patients aged ≥18 years with a RACE score ≥4, a pre-stroke mRS score ≤1, and suspected intracranial LVO within 6 hours of onset. Hospitals in the exposure group utilize an Emergency Stroke Unit equipped with a sliding NeuAngio-CT/DSA hybrid suite, while control hospitals follow the conventional imaging workflow.
Study Outcomes: The primary outcome is the proportion of patients achieving functional independence at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2. The primary safety outcome is the proportion of patients with all-cause mortality at 7 days or at the time of hospital discharge.
Detailed description
This study employs a multicenter, matched-cluster controlled design wherein 5 to 10 hospitals equipped with Neusoft Medical's domestic sliding-gantry Angio-CT/Digital Subtraction Angiography (ACT/DSA) system, and staffed by personnel who have completed standardized operational training, will be selected as the Exposure Group, while a corresponding 5 to 10 matched hospitals lacking this integrated system will serve as the Control Group. In the Exposure Group, the protocol dictates an optimized direct-to-angiography suite workflow; upon arrival, patients undergo immediate neurological evaluation utilizing the Rapid Arterial oCclusion Evaluation (RACE) scale and stat laboratory testing before being transferred directly to the angio suite. Intra-suite imaging is then acquired via the sliding-gantry system to perform non-contrast computed tomography (NCCT) and CT angiography (CTA). If a large vessel occlusion (LVO) is confirmed-specifically involving the M1/M2, P1, A1, or basilar artery (BA) segments-endovascular therapy (EVT), encompassing mechanical thrombectomy, balloon angioplasty, and/or stenting, is initiated immediately on the same table. For patients without an identified LVO, intravenous thrombolysis (IVT) is administered in situ if clinical eligibility is met. Conversely, patients in the Control Group will adhere to standard-of-care diagnostic pathways, undergoing initial cross-sectional neuroimaging (NCCT/CTA or MRI/MRA) in a conventional Radiology Department, where IVT is administered in accordance with current guidelines; if an LVO is radiologically confirmed during this standard workflow, patients are subsequently transferred to a separate angiography suite to undergo EVT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure: one-stop workflow with hybrid sliding NeuAngio-CT/DSA system | – | –After patients arrive at the emergency room, they undergo neurological function assessments (RACE) and routine laboratory tests; eligible patients are then treated according to the one-stop workflow with hybrid sliding NeuAngio-CT/DSA system. |
| Control: conventional workflow with CT and DSA | – | –After patients arrive at the emergency room, they undergo neurological function assessments (RACE, NIHSS, mRS scores) and routine laboratory tests; eligible patients are then treated according to the conventional workflow with CT and DSA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It includes patients aged ≥18 years with a RACE score ≥4, a pre-stroke mRS score ≤1, and suspected intracranial LVO within 6 hours of onset. Hospitals in the exposure group utilize an Emergency Stroke Unit equipped with a sliding NeuAngio-CT/DSA hybrid suite, while control hospitals follow the conventional imaging workflow.
Key inclusion criteria (6 listed)
Key exclusion criteria (19 listed)
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
Proportion of patients with mRS score 0-2 at 90 days
Time frame: at 90 days
Scores on the modified Rankin scale (mRS) range from 0 (no neurologic deficit) to 6 (death).
12 secondary outcomes
Proportion of patients with mRS score 0-3 at 90 days
Time frame: at 90 days
Ordinal (shift) analysis of mRS at 90 days
Time frame: at 90 days
Length of hospital stay
Time frame: From date of enrollment until the date of discharge, assessed up to 3 months
Hospitalization cost
Time frame: From date of enrollment until the date of discharge, assessed up to 3 months
Incidence of neurological deterioration within 24 hours after enrollment
Time frame: within 24 hours after enrollment
Incidence of neurological deterioration at 7 days/discharge;
Time frame: at 7 days/discharge
Proportion of patients with "early efficacy (NIHSS score decrease ≥10 points, or NIHSS score 0-1)" at 7 days of hospitalization/discharge
Time frame: at 7 days or at discharge
Change in infarct volume at 24 hours (±3 hours) (median difference), assessed by central laboratory using MR T2/Flair or CT (evaluated in patients who received endovascular therapy)
Time frame: at 24 hours (±3 hours)
Proportion of patients with mTICI > 2b (evaluated in patients who received endovascular therapy)
Time frame: immediately after the intervention
Median DPT time measurement (door-to-arterial puncture time) (evaluated in patients who received endovascular therapy)
Time frame: door-to-arterial puncture time，recorded immediately after the intervention
Median DRT time measurement (door-to-reperfusion time) (evaluated in patients who received endovascular therapy)
Time frame: door-to-reperfusion time，recorded immediately after the intervention
Median DNT time measurement (door-to-needle time) (evaluated in patients who received IVT)
Time frame: door-to-needle time，recorded immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Zeguang Ren, Dr. study director
Beijing Tiantan Hospital
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 Acute Ischemic Stroke, run by Beijing Tiantan 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 6 inclusion and 19 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: opening soon, as of the sponsor's last update on 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang, Dr. (59978555, yongjunwang@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with mRS score 0-2 at 90 days (time frame: at 90 days). 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 6 Mar 2026.