Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
Recruiting now · Phase 2
Conditions studied: Acute Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT05789823
- Run by
- Capital Medical University
- People needed
- 160
- Starts
- 2023-11-01
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2025-03-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Tianjin Huanhu Hospital — Tianjin, Tianjin Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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