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NCT Number: NCT04664946

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

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neuroprotection Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intra-arterial administration of neuroprotective agents

Drug

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

Primary outcomes

  1. Proportion of server adverse events

    Time frame: 48 hours

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

Secondary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 1

    Time frame: 90 days

    Proportion of patients with modified Rankin Score 0 to 1

  2. Proportion of patients with modified Rankin Score 0 to 2

    Time frame: 90 days

    Proportion of patients with modified Rankin Score 0 to 2

  3. Modified Rankin Score

    Time frame: 90 days

    Modified Rankin Score

  4. Decrease in national institutes of health stroke scale (NIHSS)

    Time frame: 48 hours

    Decrease in NIHSS scoring at 48 hours after the treatment

  5. Proportion of symptomatic intracranial hemorrhage (sICH)

    Time frame: 48 hours

    sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

  6. Proportion of intraparenchymal hemorrhage (PH1 and PH2)

    Time frame: 48 hours

    Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment

  7. Changes in cerebral edema

    Time frame: 48 hours

    Cerebral edema was determined by cerebral volume or midline shift

  8. All causes of death within 48 hours after the treatment

    Time frame: 48 hours

    All causes of death within 48 hours after the treatment

  9. Differences in serum factors levels in different artery region

    Time frame: 0 hour

    Differences in serum factors levels in different Bessel region before recanalization

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Sheng T Chen, Ph.D.

CONTACT

[email protected]

+8613352452086

Sponsors and collaborators

Lead sponsor

Hui-Sheng Chen

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2020
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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