Recruiting NCT04664946
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)
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: Intra-arterial administration of neuroprotective agents.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Neuroprotection. Basic parameters: from 18 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 →
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Official title
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
Overview
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.
Interventions
- Drug Intra-arterial administration of neuroprotective agents
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
Primary outcome measures
- Proportion of server adverse events [Time frame: 48 hours]
Secondary outcome measures (9)
- Proportion of patients with modified Rankin Score 0 to 1 [Time frame: 90 days]
- Proportion of patients with modified Rankin Score 0 to 2 [Time frame: 90 days]
- Modified Rankin Score [Time frame: 90 days]
- Decrease in national institutes of health stroke scale (NIHSS) [Time frame: 48 hours]
- Proportion of symptomatic intracranial hemorrhage (sICH) [Time frame: 48 hours]
- Proportion of intraparenchymal hemorrhage (PH1 and PH2) [Time frame: 48 hours]
- Changes in cerebral edema [Time frame: 48 hours]
- All causes of death within 48 hours after the treatment [Time frame: 48 hours]
- Differences in serum factors levels in different artery region [Time frame: 0 hour]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Neurology, General Hospital of Northern Theater Command — Shenyang
Identifiers
NCT: NCT04664946 · k（2020）31