Local ischemic postconditioning for acute ischemic stroke patients
RAPID Local Ischemic Postconditioning in Acute Ischemic Stroke pAtients receiVEd Successful Thrombectomy Reperfusion
NA · Shanghai Jiao Tong University Affiliated Sixth People's Hospital · NCT06526429
This study is testing a new method that temporarily stops blood flow to help the brain recover better after a stroke in patients who have had a successful procedure to remove a blood clot.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital (other) |
| Locations | 2 sites (Shanghai and 1 other locations) |
| Trial ID | NCT06526429 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and optimal dosing of rapid local ischemic postconditioning in patients with acute ischemic stroke who have undergone successful mechanical thrombectomy. The approach involves temporarily halting blood flow using balloon inflation and deflation to allow the brain tissue to adapt to intermittent blood flow restoration. The trial employs a Bayesian Optimal Interval design to adaptively assign patients to the most effective dose based on toxicity and efficacy. A total of 60 participants will be enrolled to evaluate the safety outcomes within 7 days post-intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic large vessel occlusion acute ischemic stroke treated with successful mechanical thrombectomy.
Not a fit: Patients with significant stenosis in the proximal middle cerebral artery or internal carotid artery may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance neuroprotection and improve recovery outcomes for patients suffering from acute ischemic stroke.
How similar studies have performed: While the approach of ischemic postconditioning is being explored, this specific trial design and methodology may be novel and untested in the context of acute ischemic stroke.
Eligibility criteria
Show full inclusion / exclusion criteria
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, 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
Where this trial is running
Shanghai and 1 other locations
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital — Shanghai, China (RECRUITING)
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital — Shanghai, China (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Yueqi Zhu, MD — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study coordinator: Yueqi Zhu, MD
- Email: zhuyueqi@hotmail.com
- Phone: 0086-21-64844183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Ischemic Stroke, Mechanical Thrombectomy, Ischemic Postconditioning, Brain Edema, Neuroprotection