Neuroprotective treatment for patients with ischemic stroke undergoing endovascular therapy
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): One Single Center, Safety and Feasibility Study
This study is testing a new treatment that delivers protective medicine directly into the arteries of stroke patients during a procedure to see if it helps them recover better and reduces brain damage.
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 | NCT04664933 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and feasibility of administering neuroprotective agents directly into the arteries of patients experiencing acute ischemic stroke who are undergoing endovascular treatment. The approach aims to enhance recovery and minimize brain damage during the critical period of stroke intervention. Eligible participants are those who meet specific criteria, including age and stroke severity, and who provide informed consent for the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing an acute ischemic stroke and are eligible for endovascular treatment.
Not a fit: Patients with a history of severe prior strokes or significant comorbidities such as coagulation disorders or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from acute ischemic stroke.
How similar studies have performed: While the specific approach of intra-arterial neuroprotection is novel, similar studies exploring neuroprotective strategies in stroke have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenyang
- Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.