Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

Официальное название

Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)

Обзор

The purpose of this study is to assess the safety and efficacy of endovascular thrombectomy in both an early and extended time window in patients with large strokes due to large artery occlusion.

Подробное описание

This is a pilot prospective randomized trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion who present with an eligible large ischemic core lesion, and who can be treated within 24 hours of stroke onset. The results of this pilot study will be used as preliminary data for a larger NIH-funded multi-center randomized trial to address the knowledge gaps in the management of this patient population.

Eligible patients will be randomized 1:1 to either:

Endovascular therapy plus medical therapy (based on current AHA guidelines)

or

Medical therapy (based on current AHA guidelines)

Endovascular Therapy: Patients randomized to endovascular therapy will be treated with aspiration thrombectomy devices and suction thrombectomy systems approved by the FDA for use in this study. Standard medical therapy, based on current AHA guidelines, will also be provided.

Medical Therapy: Patients randomized to medical therapy will receive standard medical therapy based on current AHA guidelines.

The researchers hope to learn if endovascular therapy plus standard medical therapy in this patient population leads to less disability after stroke than standard medical therapy alone.

Вмешательства

• Процедура EndovascularThrombectomy
  Endovascular thrombectomy is a minimally invasive procedure that uses catheters and devices to remove blood clots, restoring blood flow to the brain. The procedure involves inserting a catheter (a long, thin tube) into an artery, usually in the groin, and guiding it through the blood vessels to the site of the blocked artery/blood clot in the brain. After the catheter reaches the affected area, a specialized device is guided through the catheter to capture and remove the clot.
• Устройство Endovascular thrombectomy with any FDA-approved device
  The following FDA approved thrombectomy devices will be included: Stryker Neurovascular Products: * AXS Vecta 74 Aspiration System * AXS Vecta Aspiration System (AXS Vecta 71 Aspiration Catheter and AXS Vecta 74 Aspiration Catheter) * AXS Vecta Intermediate Catheters (AXS Vecta 71 Intermediate Catheter \& AXS Vecta 74 Intermediate Catheter) * Trevo XP ProVue Retriever, 3x20 and 4x20 * Trevo XP ProVue Retriever, 4x30 * Trevo XP ProVue Retriever, 6x25 Medtronic Products: Solitaire X Revascular

Первичные конечные точки

• Disability as measured on the modified Rankin Score [Срок оценки: 90 day]

Вторичные конечные точки (2)

• Percentage of patients with modified Rankin Scale 0-3 [Срок оценки: 90 day]
• Percentage of patients requiring hemicraniectomy [Срок оценки: from admission to discharge; up to 14 days]

Критерии участия

Критерии включения

• Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging
• Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization
• Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging
• Functionally independent prior to stroke onset
• Patient/ Legally Authorized Representative has signed the Informed Consent form.

Критерии исключения

• Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
• Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
• Pregnant
• Unable to undergo a contrast brain perfusion scan with either MRI or CT
• Known allergy to iodine that precludes an endovascular procedure
• Treated with tPA or TNK >4.5 hours after time last known well
• Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
• Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
• Baseline platelet count < 50,000/uL
• Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg)
• Current participation in another investigational drug or device study
• Presumed septic embolus; suspicion of bacterial endocarditis
• Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

NEUROIMAGING Exclusion:

• Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
• Significant mass effect with midline shift
• Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
• Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
• Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford University — Palo Alto

Идентификаторы

NCT: NCT06961487 · 74948

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗