Acute Ischemic Stroke From Large Vessel OcclusionPROMOTE-EVTNCT07042490
Efficacy and Safety of Plasma Adsorption Combined With EVT for AIS-LVO
A study testing Plasma adsorption and Endovascular Thrombectomy in people with Acute Ischemic Stroke From Large Vessel Occlusion and Endovascular Thrombectomy, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of plasma adsorption for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke From Large Vessel Occlusion, Endovascular Thrombectomy
- What is being tested?
- Plasma adsorption and Endovascular Thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, male or female.
- Diagnosis of acute ischemic stroke within 12 hours of symptom onset, underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by DSA as ICA,MCA-M1,MCA-M2,ACA-A1,ACA-A2 occlusion or tandem lesion) and achieve successful recanalization (mTICI grade 2b/3).
- Baseline NIHSS after EVT ≥ 6 and ≤25 points.
- Randomization and the first plasma adsorption can be initiated within 12 hours after EVT.
- Pre-stroke mRS≤ 2 points.
- Patient/legally family members have signed the Informed consent form.
Who cannot join
- Imaging after EVT indicated malignant brain edema with midline shift or brain herniation and surgical treatment was planned.
- Parenchymal hemorrhage type 1, or type 2 confirmed by CT.
- Allergic to any ingredient of the plasma separator, the adsorption device, or the piping.
- Contraindications to plasma adsorption, platelet count <60×10^9/L,white blood cell<4×10^9/L, uncontrolled hypertension with persistent systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg, uncontrolled hypotension, systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg.
- Previous history of malignant tumors, autoimmune diseases or being treated with immunosuppressants, hormones, or tumor necrosis factor inhibitors.
- Previous history of organic heart disease and NYHA Class III or IV.
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- Currently taking anticoagulant(dabigatran, rivaroxiban, warfarin, etc.), previous history of serious hematological system disorders, or abnormal coagulation function (international normalized ratio [INR], activated partial thromboplastin time [APTT], prothrombin time [PT] upper limit of the normal range).
- Severe liver and kidney dysfunction or abnormal laboratory test results（serum aspartate aminotransferase or alanine aminotransferase >3 times the upper limit of normal, serum creatinine>265umol/l(>3mg/dl)）.
- Pregnancy , lactation or life expectancy of less than 3 months or inability to complete the study for other reasons.
- Unwilling to be followed up or poor compliance.
- Current or past participation in other clinical research, or participation in this study within 3 months prior to admission.
- Other conditions that the researchers think make the patient unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD,PhD, 0086-13756661217, doctor_yangyi@163.com
About this study
Official title: Efficacy and Safety of Plasma Adsorption Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial
The purpose of this study is to determine the efficacy and safety of plasma adsorption for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
Read the detailed description
Large vessel occlusive (LVO) stroke has a higher mortality and disability rate than other types of acute ischemic stroke (AIS). Endovascular thrombectomy (EVT) is recommended as a standard treatment for AIS-LVO. However, even if the blood vessels are successfully recanalization, nearly one-third of the patients still die and nearly half remain disabled at 3 months. Inflammation plays a crucial role in the pathophysiological cascade of ischemic stroke and related forms of brain injury. Evidence from experimental stroke indicates that targeting cytokines may reduce infarct volume and promote functional recovery. Plasma adsorption (PA) has been applied in the treatment of severe inflammatory diseases, including pancreatitis and sepsis, as well as in the neurological autoimmune diseases, such as myasthenia gravis, multiple sclerosis, and autoimmune encephalitis. We hypothesize that PA can improve functional outcome of AIS-LVO who underwent EVT.
In this study, the experimental group receive EVT and PA, 1 time per day for 3 consecutive days. The control group receive EVT . Two groups will be followed up for 90 days to evaluate the efficacy and safety of PA for patients of AIS-LVO of anterior circulation, who achieve successful recanalization through EVT.
- Being tested
- Plasma adsorption, Endovascular Thrombectomy
- Keywords
- Acute ischemic stroke, Plasma adsorption, Endovascular Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma adsorptionProcedure or surgery
Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days.
Endovascular ThrombectomyProcedure or surgery
The patients will be treated with endovascular thrombectomy.
| Study group | Role | What they receive |
|---|---|---|
| Plasma adsorption+Endovascular Thrombectomy | Experimental | Patients are received plasma adsorption and endovascular thrombectomy.Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days. Receives: Procedure: Plasma adsorption; Procedure: Endovascular Thrombectomy |
| Endovascular Thrombectomy | Active comparator | The patients will be treated with endovascular thrombectomy . Receives: Procedure: Endovascular Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 90±7 days
Secondary outcomes (6)
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 at 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents an excellent outcome.
Measured: 90±7 days
Ordinal distribution of Modified Rankin Scale (mRS)
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).
Measured: 90±7 days
Proportion of patients with a reduction of NIHSS score（≥4 points）
The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Measured: 7 days(or discharge)
Blood lipid in peripheral blood
Blood lipid in peripheral blood，including total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides. are assessed at 72 hours and 7 days from randomization.
Measured: 72 hours, 7 days
Cytokine levels in peripheral blood
Cytokines such as pro-inflammatory factors including interleukins are assessed at 72 hours and 7 days from randomization.
Measured: 72 hours, 7 days
Final infarct volume
Final infarct volume measured with diffusion weighted imaging (DWI) MRI.
Measured: 7 days (or discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke From Large Vessel OcclusionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Zhenni Guo, MD,PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042490
- Sponsor's protocol ID
- PROMOTE-EVT
- Acronym
- PROMOTE-EVT
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Plasma Adsorption Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07042490
- Acronym / sponsor ID
- PROMOTE-EVT / PROMOTE-EVT
- Keywords
- Acute ischemic stroke, Plasma adsorption, Endovascular Thrombectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jun 2025 (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.
The purpose of this study is to determine the efficacy and safety of plasma adsorption for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
Detailed description
Large vessel occlusive (LVO) stroke has a higher mortality and disability rate than other types of acute ischemic stroke (AIS). Endovascular thrombectomy (EVT) is recommended as a standard treatment for AIS-LVO. However, even if the blood vessels are successfully recanalization, nearly one-third of the patients still die and nearly half remain disabled at 3 months. Inflammation plays a crucial role in the pathophysiological cascade of ischemic stroke and related forms of brain injury. Evidence from experimental stroke indicates that targeting cytokines may reduce infarct volume and promote functional recovery. Plasma adsorption (PA) has been applied in the treatment of severe inflammatory diseases, including pancreatitis and sepsis, as well as in the neurological autoimmune diseases, such as myasthenia gravis, multiple sclerosis, and autoimmune encephalitis. We hypothesize that PA can improve functional outcome of AIS-LVO who underwent EVT.
In this study, the experimental group receive EVT and PA, 1 time per day for 3 consecutive days. The control group receive EVT . Two groups will be followed up for 90 days to evaluate the efficacy and safety of PA for patients of AIS-LVO of anterior circulation, who achieve successful recanalization through EVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma adsorption+Endovascular Thrombectomy | Experimental | Procedure: Plasma adsorption, Procedure: Endovascular ThrombectomyPatients are received plasma adsorption and endovascular thrombectomy.Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days. |
| Endovascular Thrombectomy | Active comparator | Procedure: Endovascular ThrombectomyThe patients will be treated with endovascular thrombectomy . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years, male or female.
- Diagnosis of acute ischemic stroke within 12 hours of symptom onset, underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by DSA as ICA,MCA-M1,MCA-M2,ACA-A1,ACA-A2 occlusion or tandem lesion) and achieve successful recanalization (mTICI grade 2b/3).
- Baseline NIHSS after EVT ≥ 6 and ≤25 points.
- Randomization and the first plasma adsorption can be initiated within 12 hours after EVT.
- Pre-stroke mRS≤ 2 points.
Key exclusion criteria (12 listed)
- Imaging after EVT indicated malignant brain edema with midline shift or brain herniation and surgical treatment was planned.
- Parenchymal hemorrhage type 1, or type 2 confirmed by CT.
- Allergic to any ingredient of the plasma separator, the adsorption device, or the piping.
- Contraindications to plasma adsorption, platelet count <60×10^9/L,white blood cell<4×10^9/L, uncontrolled hypertension with persistent systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg, uncontrolled hypotension, systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg.
- Previous history of malignant tumors, autoimmune diseases or being treated with immunosuppressants, hormones, or tumor necrosis factor inhibitors.
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 |
|---|---|---|
| Plasma adsorptionPlasma adsorption was initiated after endovascular thrombectomy once daily for 3 days. | Procedure or surgery | Plasma adsorption+Endovascular Thrombectomy |
| Endovascular ThrombectomyThe patients will be treated with endovascular thrombectomy. | Procedure or surgery | Endovascular Thrombectomy, Plasma adsorption+Endovascular Thrombectomy |
Primary outcome
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Time frame: 90±7 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
6 secondary outcomes
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 at 90 days
Time frame: 90±7 days
Ordinal distribution of Modified Rankin Scale (mRS)
Time frame: 90±7 days
Proportion of patients with a reduction of NIHSS score（≥4 points）
Time frame: 7 days(or discharge)
Blood lipid in peripheral blood
Time frame: 72 hours, 7 days
Cytokine levels in peripheral blood
Time frame: 72 hours, 7 days
Final infarct volume
Time frame: 7 days (or discharge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
Zhenni Guo, MD,PhD principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma adsorption and Endovascular Thrombectomy in people with Acute Ischemic Stroke From Large Vessel Occlusion and Endovascular Thrombectomy, run by Yi Yang 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang (0086-13756661217, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days (time frame: 90±7 days). 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 29 Jun 2025.