Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China, 300350
Actively Recruiting
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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