Menu
Recruiting NCT05024292

Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

Observational Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rapid local ischemic postconditioning (RL-IPostC).
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou
  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Med — Shanghai

Identifiers

NCT: NCT05024292 · 2021MT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗