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

NCT04708730 | Completed DMC

• 1 other identifier: Y (2020) 043
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with modified Rankin Score 0 to 2

  Day 90

Secondary Outcomes (9)

• Proportion of patients with modified Rankin Score 0 to 1

  Day 90

• Changes in national institutes of health stroke scale (NIHSS)

  48 hours

• Changes in national institutes of health stroke scale (NIHSS)

  7 days

• Changes in cerebral infarct volume

  48 hours

• the occurence of stroke or other cardiovascular events

  Day 90

Study Arms (2)

DELP

EXPERIMENTAL

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

control group

NO INTERVENTION

Interventions

Delipid Extracorporeal Lipoprotein filter from Plasma DEVICE

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

DELP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: August 15, 2021
• Primary Completion: November 3, 2023
• Study Completion: February 8, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)