Ischemic Stroke
Conditions
Keywords
acute ischemic stroke, thrombectomy, thrombolysis, outcome
Brief summary
To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.
Detailed description
For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.
Interventions
PROCEDURErapid local ischemic postconditioning (RL-IPostC)
with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation
Sponsors
Zhangzhou Municipal Hospital of Fujian Province
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,; 2. Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke; 3. Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value; 4. Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital 5. The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt
Exclusion criteria
1. Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion; 2. Patients underwent rescue angioplasty or stenting after thrombectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional independence | 3 month | mRS 0-2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| early therapeutic response | on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5 | defined as a decrease in the NIHSS score of ≥10 from baseline or an NIHSS score of 0 or 1 |
| Mortality | 3 month | Mortality of 3 month after stoke onset |
| excellent functional independence | 3 month | mRS 0-1 |
| Symptomatic intracerebral hemorrhage (sICH) | 24 hours after treatment | an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) according to Heidelberg Bleeding Classification |
| malignant infarction | 24 hours after treatment | defined as infarct lesions with significant space-occupying mass effect with over 1/2 affected middle cerebral artery territory with imaging signs of herniation and/or and clinical signs of herniation requiring decompressive hemicraniectomy and/or leading to death due to direct implications of stroke |
| hemorrhagic transformation | 24 hours after treatment | according to European Cooperative Acute Stroke Study II criteria |
Countries
China
Contacts
Primary ContactYueqi Zhu, PhD
Outcome results
None listed