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)
Overview
- Phase
- Not Applicable
- Intervention
- Best medical management
- Conditions
- Stroke, Ischemic
- Sponsor
- First Affiliated Hospital of Wannan Medical College
- Enrollment
- 272
- Locations
- 13
- Primary Endpoint
- 90-day good clinical outcome
- Status
- Recruiting
- Last Updated
- 2 days ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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；
- •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;
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);
Arms & Interventions
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.
Intervention: Best medical management
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.
Intervention: Endovascular therapy
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: Endovascular therapy
Outcomes
Primary Outcomes
90-day good clinical outcome
Time Frame: 90±7 days after randomization
Good clinical outcome defined as a dichotomized mRS 0-2 outcome
Secondary Outcomes
- All-cause mortality rate(90±7 days after randomization)
- Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard(within 24±6 hours after randomization)
- Change of infarct volume from baseline to 7 days(baseline, 7 days after randomization)
- Neurofunctional deficit defined as modified Rankin Scale (mRS)(90±7 days after randomization)
- 90-day clinical outcome(90±7 days after randomization)
- Any type of intracranial hemorrhage according to Heidelberg Classification.(within 24±6 hours after randomization)
- 1 year clinical outcome(365±15 days after randomization)