NCT04708730Completed
Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)
Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP): a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
Source: ClinicalTrials.gov · Last updated 15 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 11 Jan 2021
- Start date
- 15 Aug 2021
- Primary completion date
- 3 Nov 2023
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Stroke
- NCT number
- NCT04708730
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 15 Aug 2021 to the primary completion date, 3 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3;
- Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
Lab values
- 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;
- Previous allergy to heparin or calcium;
Other
- poor recanalization (TICI 1-2a);
- hypoproteinemia;
- Unsuitable for this clinical studies assessed by researcher.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.