Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy
Capital Medical University
160 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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.
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Interventions
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.
Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05789823