Rescue Endovascular Therapy for Progressive Acute Mild Ischemic Stroke With Large Vascular Occlusion

NCT ID: NCT06155032

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2026-06-30

Brief 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. 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.

Conditions

Stroke, Ischemic; Cerebrovascular; Disorder, Occlusive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Endovascular therapy

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.

Group Type: EXPERIMENTAL

Endovascular therapy

Intervention Type: PROCEDURE

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 management

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.

Group Type: ACTIVE_COMPARATOR

Endovascular therapy

Intervention Type: PROCEDURE

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 management

Intervention Type: DRUG

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

Interventions

Endovascular therapy

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.

Intervention Type: PROCEDURE

Best medical management

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

Intervention Type: DRUG

Other Intervention Names

EVT group; Best medical management group

Eligibility Criteria

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；
• NIHSS score before randomization ≥ 6 points；
• Informed consent signed.

• 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.

Exclusion Criteria

• 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;
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

Xiangtan Central Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Hainan Medical University

OTHER_GOV

Sponsor Role: collaborator

Huang Shan People's Hospital

OTHER

Sponsor Role: collaborator

Fuyang people's hospital

OTHER

Sponsor Role: collaborator

Linyi People's Hospital

OTHER

Sponsor Role: collaborator

Jiujiang No.1 People's Hospital

OTHER

Sponsor Role: collaborator

Taihe Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiming Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

Kai Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Anhui Medical University

Locations

Fuyang People's Hospital

Fuyang, Anhui, China

Site Status: RECRUITING

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

The first Hospital of Anhui University Of Science & Technology

Huainan, Anhui, China

Site Status: RECRUITING

Huangshan City People's Hospital

Huangshan City, Anhui, China

Site Status: RECRUITING

Wan Bei General Hospital of Wanbei Coal power Group

Suzhou, Anhui, China

Site Status: RECRUITING

The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, China

Site Status: RECRUITING

Xiangyang No.1 People's Hospital

Xiangyang, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiming Zhou, PhD

Role: CONTACT

neuro_depar@hotmail.com

(++)86-(+)-553-5739543

Kai Wang, PhD

Role: CONTACT

wangkai1964@126.com

Facility Contacts

Youmeng Wang, Dr

Role: primary

Kai Wang, PhD

Role: primary

wangkai1964@126.com

Jingye Wang, PhD

Role: backup

jyewang@163.com

Tao Wang, Dr

Role: primary

Chuyuan Ni, MD

Role: primary

hssjnk2013@163.com

(++)86-(+)13855910309

Benxiao Wang, MD

Role: primary

Zhiming Zhou, PhD

Role: primary

neuro_depar@hotmail.com

(++)86-(+)-553-5739543

Xianjun Huang, PhD

Role: backup

doctorhuangxj@hotmail.com

(++)86-(+)-553-5739543

Peiyang Zhou, MD

Role: primary

13597491119@126.com

Other Identifiers

20230004

Identifier Type: -

Identifier Source: org_study_id