Intra-arterial neuroprotection for ischemic stroke patients who missed reperfusion therapy

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT04664946 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Neuroprotective drugs given systemically have largely failed in past trials and intra-arterial delivery remains experimental with limited clinical evidence to date.

Eligibility 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 this trial is running

Shenyang

• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (Recruiting)

Study contacts

• Study coordinator: Hui-Sheng T Chen, Ph.D.

Conditions Ischemic Stroke; Neuroprotection