Clinical trial NCT05024292: Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke
thrombectomy
thrombolysis
outcome
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
Collaborators: name: Zhangzhou Municipal Hospital of Fujian Province
First posted: 2021-08-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: functional independence
timeFrame: 3 month
Secondary outcomes:
measure: excellent functional independence
timeFrame: 3 month
measure: early therapeutic response
timeFrame: on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5
measure: Mortality
timeFrame: 3 month
measure: hemorrhagic transformation
timeFrame: 24 hours after treatment
measure: Symptomatic intracerebral hemorrhage (sICH)
timeFrame: 24 hours after treatment
measure: malignant infarction
timeFrame: 24 hours after treatment
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University School Of Medicine
name: Yueqi Zhu, PhD
role: STUDY_CHAIR
References: