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Recruiting NCT04664933

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)

No phase Interventional Stroke, Ischemic Intravascular Thrombosis Mechanical Thrombectomy

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: Stroke, Ischemic, Intravascular Thrombosis, Mechanical Thrombectomy. 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 →

Unsure about the terms? Read our patient guide →

Official title

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): 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 received recanalization operation.

Interventions

  • Drug Intra-arterial administration of neuroprotective agents
    Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min

Primary outcome measures

  • Proportion of server adverse events [Time frame: 48 hours]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years;
  • Acute ischemic stroke patients who is eligible for endovascular treatment;
  • Signed informed consent.

Exclusion criteria

  • Modified Rankin Score >2 caused by a history of prior stroke;
  • 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: NCT04664933 · K (2020) 32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗