Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

Ischemic Stroke Clinical Trial

— ORANGE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05024292
• Other study ID #: 2021MT
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: April 2027

Study information

• Verified date: July 2023
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: Yueqi Zhu, PhD
• Phone: +86-21-18930177565
• Email: zhuyueqi[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Zhangzhou Municipal Hospital of Fujian Province	Zhangzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Zhangzhou Municipal Hospital of Fujian Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional independence	mRS 0-2	3 month
Secondary	excellent functional independence	mRS 0-1	3 month
Secondary	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
Secondary	Mortality	Mortality of 3 month after stoke onset	3 month
Secondary	hemorrhagic transformation	according to European Cooperative Acute Stroke Study II criteria	24 hours after treatment
Secondary	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
Secondary	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