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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04664946
Recruitment Status : Active, not recruiting
First Posted : December 11, 2020
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Neuroprotection Drug: Intra-arterial administration of neuroprotective agents Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intra-arterial administration of 3-n-butylphthalide
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
 Drug: Intra-arterial administration of neuroprotective agents
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of server adverse events [ Time Frame: 48 hours ]
    server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years;
  2. Major neurologic deficits: 6≤NIHSS≤20;
  3. 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);
  4. Premorbid mRS 0 or 1;
  5. Signed informed consent.

Exclusion Criteria:

  1. Modified Rankin Score >2 caused by a history of prior stroke;
  2. Patients who underwent intravenous thrombolysis or Endovascular treatment;
  3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <80000/mm3;
  4. 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;
  5. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
  6. Unsuitable for this clinical studies assessed by researcher.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664946


Locations
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China
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016
Sponsors and Collaborators
Hui-Sheng Chen
More Information
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Responsible Party: Hui-Sheng Chen, Director, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT04664946    
Other Study ID Numbers: k（2020）31
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs