Ischemic Stroke Clinical Trial
Official title:
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
Verified date | May 2024 |
Source | General Hospital of Shenyang Military Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurology, General Hospital of Northern Theater Command | Shenyang |
Lead Sponsor | Collaborator |
---|---|
Hui-Sheng Chen |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of server adverse events | server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc. | 48 hours | |
Secondary | Proportion of patients with modified Rankin Score 0 to 1 | Proportion of patients with modified Rankin Score 0 to 1 | 90 days | |
Secondary | Proportion of patients with modified Rankin Score 0 to 2 | Proportion of patients with modified Rankin Score 0 to 2 | 90 days | |
Secondary | Modified Rankin Score | Modified Rankin Score | 90 days | |
Secondary | Decrease in national institutes of health stroke scale (NIHSS) | Decrease in NIHSS scoring at 48 hours after the treatment | 48 hours | |
Secondary | Proportion of symptomatic intracranial hemorrhage (sICH) | sICH was defined as 4 or more increase in NIHSS caused by hemorrhage | 48 hours | |
Secondary | Proportion of intraparenchymal hemorrhage (PH1 and PH2) | Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment | 48 hours | |
Secondary | Changes in cerebral edema | Cerebral edema was determined by cerebral volume or midline shift | 48 hours | |
Secondary | All causes of death within 48 hours after the treatment | All causes of death within 48 hours after the treatment | 48 hours | |
Secondary | Differences in serum factors levels in different artery region | Differences in serum factors levels in different Bessel region before recanalization | 0 hour |
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