Status:
COMPLETED
Local Ischemic Postconditioning in Acute Ischemic Stroke
Lead Sponsor:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborating Sponsors:
Zhangzhou Municipal Hospital of Fujian Province
Shanghai East Hospital
Conditions:
Acute Ischemic Stroke
Mechanical Thrombectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, in...
Detailed Description
This will be an Bayesian Optimal Interval Phase I/II (BOIN12) trial design to determine the safety and optimal dose of ischemic postconditioning intervention. The BOIN12 design makes the decision of d...
Eligibility Criteria
Inclusion
- 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
- 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, advanced hepatic and renal insufficiency, severe heart failure
- Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial
- Other circumstances that the investigator considers inappropriate for this trial
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06526429
Start Date
October 14 2024
End Date
July 20 2025
Last Update
November 28 2025
Active Locations (2)
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1
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, China, 200023
2
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, China, 200233