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

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

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

Conditions
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Ischemic Stroke, Neuroprotection

Intervention / Treatment
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* Drug: Intra-arterial administration of neuroprotective agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-arterial administration of 3-n-butylphthalide<br>Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min. | Drug: Intra-arterial administration of neuroprotective agents<br>* Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of server adverse events | server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 1 | Proportion of patients with modified Rankin Score 0 to 1 | 90 days | 
| Proportion of patients with modified Rankin Score 0 to 2 | Proportion of patients with modified Rankin Score 0 to 2 | 90 days | 
| Modified Rankin Score | Modified Rankin Score | 90 days | 
| Decrease in national institutes of health stroke scale (NIHSS) | Decrease in NIHSS scoring at 48 hours after the treatment | 48 hours | 
| Proportion of symptomatic intracranial hemorrhage (sICH) | sICH was defined as 4 or more increase in NIHSS caused by hemorrhage | 48 hours | 
| Proportion of intraparenchymal hemorrhage (PH1 and PH2) | Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment | 48 hours | 
| Changes in cerebral edema | Cerebral edema was determined by cerebral volume or midline shift | 48 hours | 
| All causes of death within 48 hours after the treatment | All causes of death within 48 hours after the treatment | 48 hours | 
| Differences in serum factors levels in different artery region | Differences in serum factors levels in different Bessel region before recanalization | 0 hour |