Local Ischemic Postconditioning in Acute Ischemic Stroke (NCT06526429) | Clinical Trial Compass
CompletedNot Applicable
Local Ischemic Postconditioning in Acute Ischemic Stroke
China25 participantsStarted 2024-10-14
Plain-language summary
This study aims to determine the safety and optimal dose of rapid local ischemic postconditioning in acute ischemic stroke(AIS) patients received successful thrombectomy reperfusion. In this trial, investigators will halt antegrade cerebral blood flow temporarily by the way of balloon guiding catheter (BGC) 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. The optimal postconditioning intervention dose will be determined for further investigation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old
* Presenting with symptoms and signs consistent with acute anterior circulation ischemic stroke
* Pre-stroke modified Rankin Score 0-1
* Baseline National Institute of Health Stroke Scale (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 (MCA) (M1 or M2) and is the culprit artery
* Ischemic core volume is \< 70 ml, mismatch ratio is \>1.8 and mismatch volume is \>15 ml as determined by CT perfusion imaging
* Embolism verified as the etiology of occluded artery and modified Thrombolysis in Cerebral Infarction Score (mTICI) 2b or 3 achieved after mechanical thrombectomy.
* Time from CT perfusion to reperfusion \< 2 hours
* Informed consent signed
Exclusion Criteria:
* Stenosis of the proximal middle cerebral artery, internal carotid artery, or common carotid artery (≥50%) of the culprit artery
* Evidence of internal carotid artery lesion that precludes the access and application of balloon guide catheter
* Multiple vascular embolism on different pathways (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
* Pre ischemic stroke within past 3 months
* The expected survival time is less than 6 months, could not be followed at 90 days (such as patient with malignant tumor)
* Currently pregnant, mental disease, advanc…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: within 7 days
Trial details
NCT IDNCT06526429
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital