Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)
Study Details
Study Description
Brief Summary
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who received recanalization operation.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intra-arterial administration of 3-n-butylphthalide Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min. |
Drug: Intra-arterial administration of neuroprotective agents
Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min
|
Outcome Measures
Primary Outcome Measures
- Proportion of server adverse events [48 hours]
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
Secondary Outcome Measures
- Proportion of patients with modified Rankin Score 0 to 1 [90 days]
Proportion of patients with modified Rankin Score 0 to 1
- Proportion of patients with modified Rankin Score 0 to 2 [90 days]
Proportion of patients with modified Rankin Score 0 to 2
- Modified Rankin Score [90 days]
Modified Rankin Score
- Decrease in national institutes of health stroke scale (NIHSS) [48 hours]
Decrease in NIHSS scoring at 48 hours after the treatment
- Proportion of symptomatic intracranial hemorrhage (sICH) [48 hours]
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
- Proportion of intraparenchymal hemorrhage (PH1 and PH2) [48 hours]
Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment
- Changes in cerebral edema [48 hours]
Cerebral edema was determined by cerebral volume or midline shift
Other Outcome Measures
- Differences in serum factors levels and blood gas in diverse vessel region [Hour 0]
Differences in serum factors levels and blood gas in diverse vessel region
- Changes in serum factors levels [30 minutes, 24 hours]
changes in serum factors levels before and at different timepoints after recanalization
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years;
-
Acute ischemic stroke patients who is eligible for endovascular treatment;
-
Signed informed consent.
Exclusion Criteria:
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Modified Rankin Score >2 caused by a history of prior stroke;
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Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<80000/mm3);
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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;
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Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
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Unsuitable for this clinical studies assessed by researcher.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Neurology, General Hospital of Northern Theater Command | Shenyang | China | 110016 |
Sponsors and Collaborators
- Hui-Sheng Chen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K (2020) 32