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CompletedNCT04708730Updated Mar 15, 2024

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

An interventional study of Delipid Extracorporeal Lipoprotein filter from Plasma in Ischemic Stroke, sponsored by General Hospital of Shenyang Military Region. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by General Hospital of Shenyang Military Region · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    DELP

    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

  • No intervention
    control group

Interventions

  • DeviceDelipid Extracorporeal Lipoprotein filter from Plasma

    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

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What researchers measure

Primary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 2

    Time frame: Day 90

Secondary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 1

    Time frame: Day 90

  2. 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.

    Time frame: 48 hours

  3. 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.

    Time frame: 7 days

  4. Changes in cerebral infarct volume

    Time frame: 48 hours

  5. the occurence of stroke or other cardiovascular events

    Time frame: Day 90

  6. the occurence of infections post stroke

    Time frame: Day 14

  7. Proportion of symptomatic intracranial hemorrhage (sICH)

    sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

    Time frame: 48 hours

  8. Proportion of intraparenchymal hemorrhage (PH1 and PH2)

    Time frame: 48 hours

  9. the occurence of death due to any cause

    Time frame: Day 90

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Study locations

1 site
  • Department of Neurology, General Hospital of Northern Theater Command
    Shenyang, 110016, China
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References and documents

Individual participant data

Plan to share: Yes — IPD will be shared in request after the trial finish and will include study protocol, statistical analysis plan.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04708730
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (Head of Neurology, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Jan 14, 2021
Start date
Aug 15, 2021
Primary completion
Nov 3, 2023
Completion
Feb 8, 2024
Last update
Mar 15, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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