RecruitingNot ApplicableNCT04664946

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study


Sponsor

Hui-Sheng Chen

Enrollment

30 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥18 years;
  • Major neurologic deficits: 6≤NIHSS≤20;
  • Missing recanalization therapy (IVT or EVT) or progressive stroke, which was defined as symptoms worsen in 48 hours (an increase in NIHSS more than 4);
  • Premorbid mRS 0 or 1;
  • Signed informed consent.

Exclusion Criteria6

  • Modified Rankin Score >2 caused by a history of prior stroke;
  • Patients who underwent intravenous thrombolysis or Endovascular treatment;
  • Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <80000/mm3;
  • Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
  • Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
  • Unsuitable for this clinical studies assessed by researcher.

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Interventions

DRUGIntra-arterial administration of neuroprotective agents

Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.


Locations(1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China

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