Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

Shanghai Jiao Tong University Affiliated Sixth People's Hospital160 enrolled

Overview

To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Ischemic Stroke

Interventions

rapid local ischemic postconditioning (RL-IPostC)PROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (2)

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

RECRUITING

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

functional independence

mRS 0-2

Time frame: 3 month

Secondary Outcomes

excellent functional independence

mRS 0-1

Time frame: 3 month

early therapeutic response

defined as a decrease in the NIHSS score of ≥10 from baseline or an NIHSS score of 0 or 1

Time frame: on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5

Mortality

Mortality of 3 month after stoke onset

Time frame: 3 month

hemorrhagic transformation

according to European Cooperative Acute Stroke Study II criteria

Time frame: 24 hours after treatment

Symptomatic intracerebral hemorrhage (sICH)

an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) according to Heidelberg Bleeding Classification

Time frame: 24 hours after treatment

malignant infarction

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

Time frame: 24 hours after treatment

Central Contacts

Yueqi Zhu, PhD

CONTACT

+86-21-18930177565 zhuyueqi@hotmail.com

Data from ClinicalTrials.gov

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