Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment (ORANGE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: rapid local ischemic postconditioning (RL-IPostC)

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Yueqi Zhu, PhD; Phone Number: +86-21-18930177565; Email: zhuyueqi@hotmail.com

Study Locations

• China
  • Shanghai, China, 200233
    • Recruiting
    • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: Jiangshan Deng, PhD; Phone Number: 02164369181; Email: johnson120@126.com
  • Fujian
    • Zhangzhou, Fujian, China
      • Recruiting
      • Zhangzhou Municipal Hospital of Fujian Province
      • Contact: Wenhuo Chen, MD; Phone Number: +86-596-2082950; Email: doctorwwenhuo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients were treated according to national guidelines for treatment of AIS, including intravenous thrombolysis, if indicated. Thrombectomy were performed according to standard techniques. The method of endovascular therapy was selected at the discretion of treating physicians and could include stent retriever and/or catheter aspiration.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; no intervention was provided after successful reperfusion
rapid local ischemic postconditioning (RL-IPostC) group; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional independence	mRS 0-2	3 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Collaborators: Zhangzhou Municipal Hospital of Fujian Province
• Investigators: Study Chair: Yueqi Zhu, PhD, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 22, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: thrombolysis; outcome; acute ischemic stroke; thrombectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2021MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No