Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)

Study Overview
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Brief Summary
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Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). Our recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, DELP was used to investigate the effect on acute ischemic stroke receiving endovascular treatment.

Official Title
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Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP): a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Delipid Extracorporeal Lipoprotein filter from Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years; acute anterior circulatory cerebral infarction with large vessel occlusion; NIHSS≥6 before endovascular treatment; good recanalization (TICI 2b-3); time from onset to groin puncture is less than 8 hours; time from recanalization to DELP is less than 2 hours; Premorbid mRS 0 or 1; Signed informed consent. Exclusion Criteria: poor recanalization (TICI 1-2a); Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3; 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; Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg); Previous allergy to heparin or calcium; hypoproteinemia; Unsuitable for this clinical studies assessed by researcher.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DELP<br>Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration | Device: Delipid Extracorporeal Lipoprotein filter from Plasma<br>* As a non-pharmacological therapy, Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) hase been approved by China Food and Drug Administration to treat acute stroke<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 2 |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 1 |  | Day 90 | 
| Changes in national institutes of health stroke scale (NIHSS) | NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit. | 48 hours | 
| Changes in national institutes of health stroke scale (NIHSS) | NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit. | 7 days | 
| Changes in cerebral infarct volume |  | 48 hours | 
| the occurence of stroke or other cardiovascular events |  | Day 90 | 
| the occurence of infections post stroke |  | Day 14 | 
| Proportion of symptomatic intracranial hemorrhage (sICH) | sICH was defined as 4 or more increase in NIHSS caused by hemorrhage | 48 hours | 
| Proportion of intraparenchymal hemorrhage (PH1 and PH2) |  | 48 hours | 
| the occurence of death due to any cause |  | Day 90 |