Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
China160 participantsStarted 2023-11-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
✕. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;