Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05789823

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

Led by Capital Medical University · Updated on 2025-03-26

160

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute ischemic stroke within 24 hours from stroke onset or last known well time to groin puncture
  • Modified Rankin Scale score of 2 or less before the stroke
  • Baseline National Institutes of Health Stroke Scale score of 6 or more
  • Baseline Alberta Stroke Program Early CT Score of 6 or more
  • Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion
  • Successful recanalization after mechanical thrombectomy with eTICI score between 2b and 3
  • Written informed consent provided by the patient or their legal representative
Not Eligible

You will not qualify if you...

  • Confirmed or suspected cerebral vasculitis or fibromuscular dysplasia
  • Difficulty positioning the balloon for ischemic post-conditioning
  • Complications from thrombectomy such as contrast leakage, vessel perforation or rupture, dissection, or thrombus escape
  • Stenting in the middle cerebral artery M1 segment or distal intracranial carotid artery during thrombectomy
  • More than two balloon dilations used as rescue therapy during thrombectomy
  • Contraindications to MRI
  • Any other condition deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China, 300350

Actively Recruiting

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Research Team

X

Xunming Ji, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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