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NCT05789823CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (actual)
First submitted
16 Mar 2023
Start date
1 Nov 2023
Primary completion date
16 May 2026
Lead sponsor
Capital Medical University
Diseases
Stroke
NCT number
NCT05789823

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 160
  • From 1 Nov 2023 to the primary completion date, 16 May 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;

Other illness

  • Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
  • Other conditions that the investigator considered inappropriate for inclusion.

Other

  • Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
  • Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
  • Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
  • Patients with contraindications to MRI;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Tianjin Fifth Central Hospital
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TianjinChinaUnknown status
Tianjin Huanhu Hospital
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TianjinChinaUnknown status
The Second Hospital of Tianjin Medical University
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TianjinChinaUnknown status
Qinghe people's hospital
Coordinator of this site? Confirm its status
XingtaiChinaUnknown status
Xingtai central hospital
Coordinator of this site? Confirm its status
XingtaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.