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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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 Criteria:

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

Exclusion Criteria:

  1. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
  2. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
  3. Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
  4. Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
  5. > 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
  6. Patients with contraindications to MRI;
  7. Other conditions that the investigator considered inappropriate for inclusion.

Study details
    Acute Ischemic Stroke

NCT05789823

Capital Medical University

15 October 2025

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