Intra-arterial neuroprotection for ischemic stroke patients who missed reperfusion therapy
Official title: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
Run by General Hospital of Shenyang Military Region · NCT04664946 · Data updated 2026-11-12
This study will try giving neuroprotective medicine directly into an artery to help adults with acute ischemic stroke who missed clot-opening treatment or whose symptoms worsened.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang) |
| Status | Recruiting |
| Started | December 1, 2020 |
| Main results expected | May 1, 2028 |
| Study ends | May 1, 2028 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT04664946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with acute ischemic stroke, NIHSS between 6 and 20, who missed IVT or EVT or whose symptoms worsened within 48 hours, with premorbid mRS 0–1 and able to give informed consent.
✕Probably not a fit
Patients who already received intravenous thrombolysis or endovascular treatment, those with prior disabling stroke (mRS >2), major bleeding or coagulation disorders, severe organ dysfunction, or uncontrolled severe hypertension are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center interventional study delivers neuroprotective agents directly into the cerebral artery of adults with acute ischemic stroke who did not receive intravenous thrombolysis or endovascular thrombectomy, or whose deficits worsened within 48 hours. Eligible patients are adults with moderate-to-severe deficits (NIHSS 6–20) and good premorbid function (mRS 0–1). The primary focus is on safety and feasibility of the intra-arterial approach, with monitoring for hemorrhage, organ toxicity, and neurological outcomes. Treatment is performed at the Department of Neurology, General Hospital of Northern Theater Command in Shenyang without a randomized control arm.
Why it matters
Potential benefit: If successful, intra-arterial delivery of neuroprotective agents could reduce brain injury and improve recovery for patients who cannot receive standard reperfusion treatments.
How similar studies have gone: Neuroprotective drugs given systemically have largely failed in past trials and intra-arterial delivery remains experimental with limited clinical evidence to date.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China Recruiting
Study contacts
- Study coordinator: Hui-Sheng T Chen, Ph.D.
- Email: chszh@aliyun.com
- Phone: +8613352452086
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.