Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)
1 other identifier
interventional
30
1 country
1
Brief Summary
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 21, 2025
August 1, 2025
5.4 years
November 30, 2020
August 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of server adverse events
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
48 hours
Secondary Outcomes (9)
Proportion of patients with modified Rankin Score 0 to 1
90 days
Proportion of patients with modified Rankin Score 0 to 2
90 days
Modified Rankin Score
90 days
Decrease in national institutes of health stroke scale (NIHSS)
48 hours
Proportion of symptomatic intracranial hemorrhage (sICH)
48 hours
- +4 more secondary outcomes
Study Arms (1)
Intra-arterial administration of 3-n-butylphthalide
EXPERIMENTALIntra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
Interventions
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hui-Sheng Chenlead
Study Sites (1)
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 11, 2020
Study Start
December 1, 2020
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
August 21, 2025
Record last verified: 2025-08