Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)

Официальное название

Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy

Обзор

Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

Вмешательства

• Процедура Mechanical thrombectomy combined with ischemic post-conditioning
  Ischemic post-conditioning will be applied after successful recanalization of the culprit artery achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
• Процедура Mechanical thrombectomy alone
  Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.

Первичные конечные точки

• Infarct volume at 24 hours [Срок оценки: 24 hours after randomization]

Вторичные конечные точки (12)

• Progression of infarct volume between baseline and 24 hours [Срок оценки: Baseline and 24 hours after randomization]
• Progression of perfusion defect from baseline to 24 hours [Срок оценки: Baseline and 24 hours after randomization]
• Progression of infarct volume between 2 hours and 24 hours [Срок оценки: 2 hours after randomization and 24 hours after randomization]
• Infarct volume at 5 days/at discharge [Срок оценки: 5 days after randomization or at discharge]
• The proportion of functional independence at 90 days [Срок оценки: 90 days after randomization]
• The proportion of favorable outcome at 90 days [Срок оценки: 90 days after randomization]
• The distribution of mRS score at 90 days [Срок оценки: 90 days after randomization]
• National Institute of Health Stroke Scale (NIHSS) score at 24 hours [Срок оценки: 24 hours after randomization]
• The proportion of early neurological improvement [Срок оценки: Baseline and 24 hours after randomization]
• National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge [Срок оценки: 5 days after randomization or at discharge]
• Recanalization rate at 24 hours [Срок оценки: 24 hours after randomization]
• Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization. [Срок оценки: 24 hours after randomization]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
• Previous mRS ≤ 2;
• Baseline NIHSS ≥ 6;
• Baseline ASPECTS ≥ 6;
• Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion;
• Successful recanalization after mechanical thrombectomy (eTICI 2b-3);
• Written informed consent provided by the patients or their legal relatives.

Критерии исключения

• Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
• Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
• Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
• Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
• > 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
• Patients with contraindications to MRI;
• Other conditions that the investigator considered inappropriate for inclusion.

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

Китай · 1 центр

• Tianjin Huanhu Hospital — Тяньцзинь

Публикации

• Wu L, Wei M, Zhang B, Zhang B, Chen J, Wang S, Luo L, Liu S, Li S, Ren C, Hess DC, Song H, Zhao W, Ji X. Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke. Stroke. 2023 Sep;54(9):2442-2445. doi: 10.1161/STROKEAHA.123.044060. Epub 2023 Jul 27. PMID 37497674
• Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022. PMID 36523440

Идентификаторы

NCT: NCT05789823 · PROTECT-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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