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

Shanghai Jiao Tong University Affiliated Sixth People's Hospital2 sites in 1 country160 target enrollmentJanuary 1, 2022

ConditionsIschemic Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischemic Stroke
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Enrollment: 160
Locations: 2
Primary Endpoint: functional independence
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2022

End Date

April 2027

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Responsible Party

Principal Investigator

Yueqi Zhu

Associated dean of the radiology

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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

Outcomes

Primary Outcomes

functional independence

Time Frame: 3 month

mRS 0-2

Secondary Outcomes

excellent functional independence(3 month)
early therapeutic response(on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5)
Mortality(3 month)
hemorrhagic transformation(24 hours after treatment)
Symptomatic intracerebral hemorrhage (sICH)(24 hours after treatment)
malignant infarction(24 hours after treatment)