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

ConditionsIschemic StrokeNeuroprotection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHui-Sheng Chen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Intra-arterial administration of neuroprotective agents

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intra-arterial administration of 3-n-butylphthalideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of server adverse events

server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.

Time frame
48 hours

Secondary outcomes

1

Proportion of patients with modified Rankin Score 0 to 1

Proportion of patients with modified Rankin Score 0 to 1

Time frame
90 days
2

Proportion of patients with modified Rankin Score 0 to 2

Proportion of patients with modified Rankin Score 0 to 2

Time frame
90 days
3

Modified Rankin Score

Modified Rankin Score

Time frame
90 days
4

Decrease in national institutes of health stroke scale (NIHSS)

Decrease in NIHSS scoring at 48 hours after the treatment

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hui-Sheng Chen

Lead sponsor

General Hospital of Shenyang Military Region

Sponsor institution

Source ClinicalTrials.gov
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