Endovascular therapy for mild ischemic stroke with large vessel occlusion

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)

This study is testing if a special procedure called endovascular therapy can help people who have had a mild stroke with worsening symptoms feel better compared to just receiving standard medical care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 272 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Wannan Medical College (Academic / other)
• Locations: 7 sites (Fuyang, Anhui and 6 other locations)
• Trial ID: NCT06155032 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of endovascular therapy (EVT) combined with best medical management for patients experiencing a mild ischemic stroke due to large vessel occlusion (LVO) who have shown early neurological deterioration. Approximately 272 patients aged 18 and older will be enrolled and randomized into two groups: one receiving only medical management and the other receiving EVT in addition to medical management. The study aims to determine if EVT can improve outcomes in patients who present with a minor stroke and experience symptom progression more than 24 hours after the onset. The primary endpoint is the rate of favorable outcomes measured by the modified Rankin scale at 90 days post-treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a mild ischemic stroke with an NIHSS score of less than 6 and show early neurological deterioration due to LVO.

Not a fit: Patients who do not experience early neurological deterioration or have an NIHSS score greater than 6 at the time of randomization may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with mild strokes who experience early neurological deterioration.

How similar studies have performed: While EVT has been established for more severe strokes, this specific approach for mild strokes with early deterioration is novel and has not been extensively tested in prior studies.

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;
* 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)

Where this trial is running

Fuyang, Anhui and 6 other locations

• Fuyang People's Hospital — Fuyang, Anhui, China (Recruiting)
• First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• The first Hospital of Anhui University Of Science & Technology — Huainan, Anhui, China (Recruiting)
• Huangshan City People's Hospital — Huangshan City, Anhui, China (Recruiting)
• Wan Bei General Hospital of Wanbei Coal power Group — Suzhou, Anhui, China (Recruiting)
• The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College — Wuhu, Anhui, China (Recruiting)
• Xiangyang No.1 People's Hospital — Xiangyang, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Zhiming Zhou, PhD — The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College
• Study coordinator: Zhiming Zhou, PhD

Conditions Stroke, Ischemic; Cerebrovascular; Disorder, Occlusive; endovascular therapy; mild stroke; neurological deterioration