Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Procedure: rapid local ischemic postconditioning (RL-IPostC)

• Registration Number: NCT05024292
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Study First Posted: 2021-08-27
• Study Start: 2022-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12
• Primary Completion: 2026-12
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rapid local ischemic postconditioning (RL-IPostC) group	rapid local ischemic postconditioning (RL-IPostC)	RL-IPostC is 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.

Primary Outcome Measures

Name	Time	Method
functional independence	3 month	mRS 0-2

Secondary Outcome Measures

Name	Time	Method
excellent functional independence	3 month	mRS 0-1
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
hemorrhagic transformation	24 hours after treatment	according to European Cooperative Acute Stroke Study II criteria
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

Trial Locations

Locations (2)

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Zhangzhou Municipal Hospital of Fujian Province; 🇨🇳 Zhangzhou, Fujian, China