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

August 20, 2025 updated by: Hui-Sheng Chen

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): One Single Center, Safety and Feasibility Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shenyang, China, 110016
        • Recruiting
        • Department of Neurology, General Hospital of Northern Theater Command
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-arterial administration of 3-n-butylphthalide
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of server adverse events
Time Frame: 48 hours
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of symptomatic intracranial hemorrhage (sICH)
Time Frame: 48 hours
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
48 hours
Proportion of patients with modified Rankin Score 0 to 1
Time Frame: 90 days
Proportion of patients with modified Rankin Score 0 to 1
90 days
Proportion of patients with modified Rankin Score 0 to 2
Time Frame: 90 days
Proportion of patients with modified Rankin Score 0 to 2
90 days
Modified Rankin Score
Time Frame: 90 days
Modified Rankin Score
90 days
Decrease in national institutes of health stroke scale (NIHSS)
Time Frame: 48 hours
Decrease in NIHSS scoring at 48 hours after the treatment
48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Time Frame: 48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment
48 hours
Changes in cerebral edema
Time Frame: 48 hours
Cerebral edema was determined by cerebral volume or midline shift
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in serum factors levels and blood gas in diverse vessel region
Time Frame: Hour 0
Differences in serum factors levels and blood gas in diverse vessel region
Hour 0
Changes in serum factors levels
Time Frame: 30 minutes, 24 hours
changes in serum factors levels before and at different timepoints after recanalization
30 minutes, 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui-Sheng Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K (2020) 32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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