Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rapid local ischemic postconditioning (RL-IPostC).
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy
Overview
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
- Procedure rapid 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
Primary outcome measures
- functional independence [Time frame: 3 month]
Secondary outcome measures (6)
- excellent functional independence [Time frame: 3 month]
- early therapeutic response [Time frame: on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5]
- Mortality [Time frame: 3 month]
- hemorrhagic transformation [Time frame: 24 hours after treatment]
- Symptomatic intracerebral hemorrhage (sICH) [Time frame: 24 hours after treatment]
- malignant infarction [Time frame: 24 hours after treatment]
Eligibility criteria
Inclusion criteria
- 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,;
- 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;
- Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
- Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
- The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt
Exclusion criteria
- Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
- Patients underwent rescue angioplasty or stenting after thrombectomy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou
- Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Med — Shanghai
Identifiers
NCT: NCT05024292 · 2021MT