Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke (NCT06307743) | Clinical Trial Compass
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Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke
135 participantsStarted 2024-03-15
Plain-language summary
The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old
✓. Presenting with symptoms consistent with acute ischemic stroke
✓. Pre-stroke mRS score 0-1
✓. Baseline NIHSS score≥6
✓. Endovascular treatment can be initiated (femoral puncture) within 24 hours from stroke onset (stroke onset time is defined as last known well time)
✓. Occlusion of the intracranial internal carotid artery, or the middle cerebral artery(M1 or M2) confirmed by CTA or MRA, and is the culprit artery
✓. Alberta Stroke Program Early CT Score (ASPECTS) (based on non-contrast CT) \>5 on noncontrast computed tomography (NCCT) for stroke onset time less than 6 hours, infarct Core \< 70 ml (defined as rCBF \<30% on CT perfusion) and mismatch ratio \> 1.2 (penumbra defined as Tmax \>6 seconds volume) for stroke onset time between 6 and 24 hours.
✓. Embolism verified as the etiology of occluded artery and mTICI 2b or 3 regained after mechanical thrombectomy
Exclusion criteria
What they're measuring
1
Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events.
Timeframe: 24 hours after procedure
Trial details
NCT IDNCT06307743
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital