Ischemic StrokeNCT04708730
Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)
A study testing Delipid Extracorporeal Lipoprotein filter from Plasma in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Delipid Extracorporeal Lipoprotein filter from Plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2021to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
About this study
Official title: Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP): a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
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
- Being tested
- Delipid Extracorporeal Lipoprotein filter from Plasma
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delipid Extracorporeal Lipoprotein filter from PlasmaDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Delipid Extracorporeal Lipoprotein filter from Plasma |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with modified Rankin Score 0 to 2
Measured: Day 90
Secondary outcomes (9)
Proportion of patients with modified Rankin Score 0 to 1
Measured: 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.
Measured: 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.
Measured: 7 days
Changes in cerebral infarct volume
Measured: 48 hours
the occurence of stroke or other cardiovascular events
Measured: Day 90
the occurence of infections post stroke
Measured: Day 14
Proportion of symptomatic intracranial hemorrhage (sICH)
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Measured: 48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Measured: 48 hours
the occurence of death due to any cause
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start15 Aug 2021
- Primary completion3 Nov 2023
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708730
- Sponsor's protocol ID
- Y (2020) 043
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared in request after the trial finish and will include study protocol, statistical analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP): a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
- ClinicalTrials.gov ID
- NCT04708730
- Acronym / sponsor ID
- Y (2020) 043
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DELP | Experimental | Device: Delipid Extracorporeal Lipoprotein filter from PlasmaDelipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delipid Extracorporeal Lipoprotein filter from PlasmaAs a non-pharmacological therapy, Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) hase been approved by China Food and Drug Administration to treat acute stroke | Device | DELP |
Primary outcome
Proportion of patients with modified Rankin Score 0 to 2
Time frame: Day 90
9 secondary outcomes
Proportion of patients with modified Rankin Score 0 to 1
Time frame: Day 90
Changes in national institutes of health stroke scale (NIHSS)
Time frame: 48 hours
Changes in national institutes of health stroke scale (NIHSS)
Time frame: 7 days
Changes in cerebral infarct volume
Time frame: 48 hours
the occurence of stroke or other cardiovascular events
Time frame: Day 90
the occurence of infections post stroke
Time frame: Day 14
Proportion of symptomatic intracranial hemorrhage (sICH)
Time frame: 48 hours
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Time frame: 48 hours
the occurence of death due to any cause
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared in request after the trial finish and will include study protocol, statistical analysis plan.
Related trials for Ischemic Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 2
The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delipid Extracorporeal Lipoprotein filter from Plasma in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Score 0 to 2 (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.