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

Primary Purpose

Stroke, Ischemic, Intravascular Thrombosis, Mechanical Thrombectomy

Status
Recruiting
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 Stroke, Ischemic

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Modified Rankin Score >2 caused by a history of prior stroke;
  2. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<80000/mm3);
  3. 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;
  4. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
  5. Unsuitable for this clinical studies assessed by researcher.

Sites / Locations

  • Department of Neurology, General Hospital of Northern Theater CommandRecruiting

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 16 to 24 hours during and after the operation at 17.36 to 26.04 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

Full Information

First Posted
November 30, 2020
Last Updated
May 23, 2023
Sponsor
Hui-Sheng Chen
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1. Study Identification

Unique Protocol Identification Number
NCT04664933
Brief Title
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)
Official Title
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): One Single Center, Safety and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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
Product Manufactured in and Exported from the U.S.
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 received recanalization operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Intravascular Thrombosis, Mechanical Thrombectomy

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 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min.
Intervention Type
Drug
Intervention Name(s)
Intra-arterial administration of neuroprotective agents
Intervention Description
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 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
Other Pre-specified Outcome Measures:
Title
Differences in serum factors levels and blood gas in diverse vessel region
Description
Differences in serum factors levels and blood gas in diverse vessel region
Time Frame
Hour 0
Title
Changes in serum factors levels
Description
changes in serum factors levels before and at different timepoints after recanalization
Time Frame
30 minutes, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Sheng Chen, Ph.D.
Phone
+86 13352452086
Email
chszh@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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