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

Primary Purpose

Ischemic Stroke, Neuroprotection

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intra-arterial administration of neuroprotective agents
Sponsored by
Hui-Sheng Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology, General Hospital of Northern Theater Command

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-arterial administration of 3-n-butylphthalide

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients with modified Rankin Score 0 to 1
Proportion of patients with modified Rankin Score 0 to 1
Proportion of patients with modified Rankin Score 0 to 2
Proportion of patients with modified Rankin Score 0 to 2
Modified Rankin Score
Modified Rankin Score
Decrease in national institutes of health stroke scale (NIHSS)
Decrease in NIHSS scoring at 48 hours after the treatment
Proportion of symptomatic intracranial hemorrhage (sICH)
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment
Changes in cerebral edema
Cerebral edema was determined by cerebral volume or midline shift
All causes of death within 48 hours after the treatment
All causes of death within 48 hours after the treatment
Differences in serum factors levels in different artery region
Differences in serum factors levels in different Bessel region before recanalization

Full Information

First Posted
November 30, 2020
Last Updated
August 20, 2023
Sponsor
Hui-Sheng Chen
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1. Study Identification

Unique Protocol Identification Number
NCT04664946
Brief Title
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)
Official Title
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hui-Sheng Chen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-arterial administration of 3-n-butylphthalide
Arm Type
Experimental
Arm Description
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
Intervention Type
Drug
Intervention Name(s)
Intra-arterial administration of neuroprotective agents
Intervention Description
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
Primary Outcome Measure Information:
Title
Proportion of server adverse events
Description
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 1
Description
Proportion of patients with modified Rankin Score 0 to 1
Time Frame
90 days
Title
Proportion of patients with modified Rankin Score 0 to 2
Description
Proportion of patients with modified Rankin Score 0 to 2
Time Frame
90 days
Title
Modified Rankin Score
Description
Modified Rankin Score
Time Frame
90 days
Title
Decrease in national institutes of health stroke scale (NIHSS)
Description
Decrease in NIHSS scoring at 48 hours after the treatment
Time Frame
48 hours
Title
Proportion of symptomatic intracranial hemorrhage (sICH)
Description
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Time Frame
48 hours
Title
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Description
Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment
Time Frame
48 hours
Title
Changes in cerebral edema
Description
Cerebral edema was determined by cerebral volume or midline shift
Time Frame
48 hours
Title
All causes of death within 48 hours after the treatment
Description
All causes of death within 48 hours after the treatment
Time Frame
48 hours
Title
Differences in serum factors levels in different artery region
Description
Differences in serum factors levels in different Bessel region before recanalization
Time Frame
0 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

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

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