Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This will be an umbrella trial of testing the efficacy and safety of three postconditioning intervention doses. It will be a prospective, open-label, blinded endpoint, three-dose Bayesian Optimal Phase 2(BOP2) design trial with interim efficacy and safety monitoring. The maximum number of subjects for this trial is estimated as 135 patients. Eligible patients are 18 years or older with symptomatic large vessel occluded (LVO) AIS treated with mechanical thrombectomy (MT) achieving successful reperfusion defined as mTICI score 2b or 3. Patients will receive 5 cycles of balloon inflation/deflation at ipsilateral C1 segment of internal carotid artery (ICA) for the temporary occlusion of the restoration of antegrade blood flow. Three postconditioning intervention doses of 30s/30s, 60s/60s and 180s/180s were adopted for block and restore of blood blow. The primary outcome is a favorable binary outcome defined as no clinically meaningful brain swelling from baseline to 24 hours and no clinically meaningful infarction growth from baseline to 24 hours and no causally attributable serious adverse events (SAEs). It's a composite outcome of efficacy and safety outcome. Key secondary outcomes include efficacy outcome indicating no clinically meaningful brain swelling defined by cerebral spinal fluid (CSF) volume reduction≤5 mL from baseline to 24 hours and safety outcome indicating infarct volume growth>10 mL from baseline to 24 hours or causally attributable SAEs. Other secondary outcomes include change of brain net water uptake, midline shift and functional outcome. For each intervention dose, we will perform the interim analyses following pre-defined optimized Bayesian rule for early stopping to make a go/no-go decision when the number of enrolled patients reaches 10, 20, 30. The optimal intervention dose will be determined according to the number of patients reach the primary endpoints in different groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06307743
Study type Interventional
Source Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Contact Yueqi Zhu, MD
Phone 0086-21-64844183
Email zhuyueqi@hotmail.com
Status Not yet recruiting
Phase N/A
Start date March 15, 2024
Completion date September 15, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06113848 - Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy Phase 3
Completed NCT04069546 - The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency N/A
Active, not recruiting NCT05700097 - Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy Phase 2
Recruiting NCT06058130 - Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis N/A
Recruiting NCT04415164 - Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke Phase 4
Recruiting NCT05363397 - Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke Phase 2
Completed NCT05429658 - Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System N/A
Recruiting NCT05390580 - Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct N/A
Enrolling by invitation NCT05515393 - A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke Phase 2
Active, not recruiting NCT05070260 - ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo Phase 2/Phase 3
Terminated NCT05547412 - Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Completed NCT03366818 - New Stent Retriever, VERSI System for AIS N/A
Not yet recruiting NCT05293080 - Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE Phase 3
Not yet recruiting NCT06437431 - Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy Phase 2/Phase 3
Not yet recruiting NCT06040476 - Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS) Phase 2
Completed NCT02223273 - Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke) N/A
Completed NCT02586233 - Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke Phase 1/Phase 2
Terminated NCT01694381 - Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor Early Phase 1
Not yet recruiting NCT01594190 - Physical Activity Immediately After Acute Cerebral Ischemia N/A
Completed NCT01120301 - Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3) Phase 3