Stroke, IschemicNCT06155032
Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion
A study testing Endovascular therapy and Best medical management in people with Stroke, Ischemic and Cerebrovascular; Disorder, Occlusive, run by First Affiliated Hospital of Wannan Medical College at 7 sites in China.
Trial summary
Endovascular therapy (EVT) added on best medical management is currently recommended in acute large vascular occlusion (LVO) stroke patients with National Institutes of Health Stroke Scale (NIHSS) score >5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Cerebrovascular; Disorder, Occlusive
- What is being tested?
- Endovascular therapy and Best medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 7 sitesChina
- Study dates
- 4 Jan 2024to 30 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- General Inclusion Criteria：
- Age ≥ 18 years；
- Presenting with symptoms consistent with an AIS and the initial NIHSS score <6 points；
- Symptom progression within 7 days of first onset；
- Randomization can be finished > 24 hours of stroke onset (stroke onset time is defined as last known well time)；
- Symptom progression to randomization time ≤ 24 hours；
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- NIHSS score before randomization ≥ 6 points；
- Informed consent signed.
- Specific Neuroimaging Inclusion Criteria
- CTA or MRA proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery;
- The progression of symptoms is caused by the recurrence of cerebrovascular diseases in the same vascular region, or the pathogenesis is caused by reduced blood flow perfusion;
- NCCT ASPECTS before randomization ≥ 6
- CTP or MRP assessment shows low perfusion in the target vessel area, and meets the following criteria: core infarction volume is less than 50ml, mismatch rate is greater than or equal to 1.8, and mismatch volume is greater than 15ml.
Who cannot join
- Pre-stroke mRS score >1;
- Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes;
- The target vessel may have factors that may prevent it from completing endovascular treatment, such as a diameter less than 1.5mm, a tortuous vascular pathway, difficulty in reaching the target position with instruments, or difficulty in recovery;
- Severe stenosis or occlusion of multiple blood vessels;
- Combined with untreated intracranial aneurysms, intracranial tumors (excluding small meningiomas), or intracranial vascular malformations;
- Intracranial hemorrhage within 6 months, including cerebral parenchymal hemorrhage, ventricular hemorrhage, and subarachnoid hemorrhage;
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- Have had gastrointestinal or urinary system bleeding, acute myocardial infarction, traumatic brain injury, or undergone major surgical procedures within the past month;
- Known hemorrhagic tendency (including but not limited to): Baseline platelet count <40×109/L; on anticoagulant therapy with warfarin and International Normalized Ratio (INR) > 2 (Patients with no history or suspected coagulopathy do not need to wait for laboratory results of INR or APTT prior to enrollment) Severe heart, liver, kidney function damage or other severe late stage diseases of the system;
- Known allergies to treatment related drugs such as iodine contrast agents, etc; Known severe allergy (more than a rash) to contrast media uncontrolled by medications;
- Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
- Uncontrolled blood sugar abnormalities (less than 2.8mmol/l or greater than 22.2mmol/l);
- Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
- The expected survival time is less than 1 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.)
- Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial
- Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kai Wang, PhD contact
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Fuyang People's Hospital
Fuyang, Anhui
Youmeng Wang, Dr
- Recruiting
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Kai Wang, PhD, wangkai1964@126.com
Jingye Wang, PhD, jyewang@163.com
- Recruiting
The first Hospital of Anhui University Of Science & Technology
Huainan, Anhui
Tao Wang, Dr
- Recruiting
Huangshan City People's Hospital
Huangshan City, Anhui
Chuyuan Ni, MD, (++)86-(+)13855910309, hssjnk2013@163.com
- Recruiting
Wan Bei General Hospital of Wanbei Coal power Group
Suzhou, Anhui
Benxiao Wang, MD
- Recruiting
The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241000
Zhiming Zhou, PhD, (++)86-(+)-553-5739543, neuro_depar@hotmail.com
Xianjun Huang, PhD, (++)86-(+)-553-5739543, doctorhuangxj@hotmail.com
- Recruiting
Xiangyang No.1 People's Hospital
Xiangyang, Hubei
Peiyang Zhou, MD, 13597491119@126.com
About this study
Official title: Study of Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion--- A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (RESCUE END-LOW)
Endovascular therapy (EVT) added on best medical management is currently recommended in acute large vascular occlusion (LVO) stroke patients with National Institutes of Health Stroke Scale (NIHSS) score >5. Thus, a sizeable fraction of patients with a minor stroke that do not undergo cerebrovascular screening may experience an early neurological deterioration (END) due to LVO, possibly leading to poor long-term functional outcome. However, whether these patients may still benefit from a rescue EVT is unknown, especially in a late window (>24 hours). In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone in a late window for minor stroke patients who have experienced an LVO and END. The primary objective of the study was to establish the safety and efficacy of EVT in a late window for minor stroke patients in the anterior circulation who experienced an LVO and END.
Read the detailed description
The RESCUE END-LOW is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study. A total of approximately 272 patients (age ≥ 18 years) in a late window (>24 hours) with a minor stroke (NIHSS <6) who experienced an END and the imaging evidence of an occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. One group will receive best medical management alone the other group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. The primary objective is to establish the efficacy of EVT in a late window for patients with LVO and a minor stroke who have experienced an END. The study consists of seven visits including the day of randomization, 24 hours after randomization, 48 hours, 72 hours, 7 days or discharge, and 30 and 90 days. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The primary endpoint is the rate of modified Rankin's scale (mRS) 0-2 at 90 days. The trial is anticipated to last from December 2023 to December 2025 with 272 subjects recruited form about 30 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Yijishan Hospital, Wannan Medical College.
- Being tested
- Endovascular therapy, Best medical management
- Keywords
- endovascular therapy, mild stroke, neurological deterioration
- Medical subject headings
- Ischemic Stroke, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular therapyProcedure or surgery
Also called EVT group
Patients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting.
In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.
Best medical managementDrug
Also called Best medical management group
All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy | Experimental | Patients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting.
In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment. Receives: Procedure: Endovascular therapy |
| Best medical management | Active comparator | Patients in this group will receive best medical management alone. All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate. Receives: Procedure: Endovascular therapy; Drug: Best medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day good clinical outcome
Good clinical outcome defined as a dichotomized mRS 0-2 outcome
Measured: 90±7 days after randomization
Secondary outcomes (8)
Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below:
4 points total NIHSS at the time of diagnosis compared to immediately before worsening.
2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention.
Absence of alternative explanation for deterioration.
Measured: within 24±6 hours after randomization
Neurofunctional deficit defined as modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90±7 days after randomization
90-day clinical outcome
mRS 0-3 outcome
Measured: 90±7 days after randomization
Change of infarct volume from baseline to 7 days
The infarct volume is determined on a diffusion-weighted MRI map based on an ADC threshold of less than 620 ×10-6mm2/s or on CTP image with rCBF<30%
Measured: baseline, 7 days after randomization
All-cause mortality rate
All-cause mortality rate at 90±7 days
Measured: 90±7 days after randomization
Any type of intracranial hemorrhage according to Heidelberg Classification.
Any type of intracranial hemorrhage according to Heidelberg Classification.
Measured: within 24±6 hours after randomization
1 year clinical outcome
mRS 0-2 outcome
Measured: 365±15 days after randomization
1 year clinical outcome
mRS 0-3 outcome
Measured: 365±15 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start4 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: Best medical management Procedure: Endovascular therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Xiangtan Central Hospital, The First Affiliated Hospital of Hainan Medical University, Huang Shan People's Hospital, Fuyang people's hospital, Linyi People's Hospital, Jiujiang No.1 People's Hospital, Taihe Hospital
- Responsible party
- Sponsor
- Investigators
- Zhiming Zhou, PhD, Principal investigator, The First Affiliated Hospital, Yijishan Hospital of Wannan Medical CollegeKai Wang, PhD, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155032
- Sponsor's protocol ID
- 20230004
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2023
- Last updated
- 30 Apr 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion--- A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (RESCUE END-LOW)
- ClinicalTrials.gov ID
- NCT06155032
- Acronym / sponsor ID
- 20230004
- Keywords
- endovascular therapy, mild stroke, neurological deterioration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Xiangtan Central Hospital, The First Affiliated Hospital of Hainan Medical University, Huang Shan People's Hospital, Fuyang people's hospital, Linyi People's Hospital, Jiujiang No.1 People's Hospital, Taihe Hospital
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 4 Dec 2023 (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.
Endovascular therapy (EVT) added on best medical management is currently recommended in acute large vascular occlusion (LVO) stroke patients with National Institutes of Health Stroke Scale (NIHSS) score >5. Thus, a sizeable fraction of patients with a minor stroke that do not undergo cerebrovascular screening may experience an early neurological deterioration (END) due to LVO, possibly leading to poor long-term functional outcome. However, whether these patients may still benefit from a rescue EVT is unknown, especially in a late window (>24 hours). In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone in a late window for minor stroke patients who have experienced an LVO and END. The primary objective of the study was to establish the safety and efficacy of EVT in a late window for minor stroke patients in the anterior circulation who experienced an LVO and END.
Detailed description
The RESCUE END-LOW is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study. A total of approximately 272 patients (age ≥ 18 years) in a late window (>24 hours) with a minor stroke (NIHSS <6) who experienced an END and the imaging evidence of an occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. One group will receive best medical management alone the other group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. The primary objective is to establish the efficacy of EVT in a late window for patients with LVO and a minor stroke who have experienced an END. The study consists of seven visits including the day of randomization, 24 hours after randomization, 48 hours, 72 hours, 7 days or discharge, and 30 and 90 days. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The primary endpoint is the rate of modified Rankin's scale (mRS) 0-2 at 90 days. The trial is anticipated to last from December 2023 to December 2025 with 272 subjects recruited form about 30 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Yijishan Hospital, Wannan Medical College.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: Best medical management Procedure: Endovascular therapy
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy | Experimental | Procedure: Endovascular therapyPatients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment. |
| Best medical management | Active comparator | Procedure: Endovascular therapy, Drug: Best medical managementPatients in this group will receive best medical management alone. All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- General Inclusion Criteria：
- Age ≥ 18 years；
- Presenting with symptoms consistent with an AIS and the initial NIHSS score <6 points；
- Symptom progression within 7 days of first onset；
- Randomization can be finished > 24 hours of stroke onset (stroke onset time is defined as last known well time)；
Key exclusion criteria (15 listed)
- Pre-stroke mRS score >1;
- Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes;
- The target vessel may have factors that may prevent it from completing endovascular treatment, such as a diameter less than 1.5mm, a tortuous vascular pathway, difficulty in reaching the target position with instruments, or difficulty in recovery;
- Severe stenosis or occlusion of multiple blood vessels;
- Combined with untreated intracranial aneurysms, intracranial tumors (excluding small meningiomas), or intracranial vascular malformations;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular therapyAlso: EVT groupPatients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment. | Procedure or surgery | Best medical management, Endovascular therapy |
| Best medical managementAlso: Best medical management groupAll the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate | Drug | Best medical management |
Primary outcome
90-day good clinical outcome
Time frame: 90±7 days after randomization
Good clinical outcome defined as a dichotomized mRS 0-2 outcome
8 secondary outcomes
Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard
Time frame: within 24±6 hours after randomization
Neurofunctional deficit defined as modified Rankin Scale (mRS)
Time frame: 90±7 days after randomization
90-day clinical outcome
Time frame: 90±7 days after randomization
Change of infarct volume from baseline to 7 days
Time frame: baseline, 7 days after randomization
All-cause mortality rate
Time frame: 90±7 days after randomization
Any type of intracranial hemorrhage according to Heidelberg Classification.
Time frame: within 24±6 hours after randomization
1 year clinical outcome
Time frame: 365±15 days after randomization
1 year clinical outcome
Time frame: 365±15 days after randomization
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 30 Apr 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.
Kai Wang, PhD contact
Zhiming Zhou, PhD principal investigator
The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
Kai Wang, PhD principal investigator
The First Affiliated Hospital of Anhui Medical University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular therapy and Best medical management in people with Stroke, Ischemic and Cerebrovascular; Disorder, Occlusive, run by First Affiliated Hospital of Wannan Medical College at 7 sites 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 13 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Zhiming Zhou, PhD ((++)86-(+)-553-5739543, neuro_depar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day good clinical outcome (time frame: 90±7 days after randomization). 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 30 Apr 2026.