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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
272
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.
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
Fuyang People's Hospital
Fuyang, Anhui, China
RECRUITINGFirst Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGThe first Hospital of Anhui University Of Science & Technology
Huainan, Anhui, China
RECRUITINGHuangshan City People's Hospital
Huangshan City, Anhui, China
RECRUITINGWan Bei General Hospital of Wanbei Coal power Group
Suzhou, Anhui, China
RECRUITINGThe First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
RECRUITINGXiangyang No.1 People's Hospital
Xiangyang, Hubei, China
RECRUITING90-day good clinical outcome
Good clinical outcome defined as a dichotomized mRS 0-2 outcome
Time frame: 90±7 days after randomization
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.
Time frame: 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
Time frame: 90±7 days after randomization
90-day clinical outcome
mRS 0-3 outcome
Time frame: 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%
Time frame: baseline, 7 days after randomization
All-cause mortality rate
All-cause mortality rate at 90±7 days
Time frame: 90±7 days after randomization
Any type of intracranial hemorrhage according to Heidelberg Classification.
Any type of intracranial hemorrhage according to Heidelberg Classification.
Time frame: within 24±6 hours after randomization
1 year clinical outcome
mRS 0-2 outcome
Time frame: 365±15 days after randomization
1 year clinical outcome
mRS 0-3 outcome
Time frame: 365±15 days after randomization
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