beta
Trial Radar AI
Clinical Trial NCT07042490 (PROMOTE-EVT) for Acute Ischemic Stroke From Large Vessel Occlusion, Endovascular Thrombectomy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Efficacy and Safety of Plasma Adsorption Combined With EVT for AIS-LVO (PROMOTE-EVT) 100

Not yet recruiting
Clinical Trial NCT07042490 (PROMOTE-EVT) is an interventional study for Acute Ischemic Stroke From Large Vessel Occlusion, Endovascular Thrombectomy and is currently not yet recruiting. Enrollment is planned to begin on 30 June 2025 and continue until the study accrues 100 participants. Led by Yi Yang, this study is expected to complete by 30 June 2027. The latest data from ClinicalTrials.gov was last updated on 29 June 2025.
Brief 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.
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 pathophysio...Show More
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

Conditions
Acute Ischemic Stroke From Large Vessel OcclusionEndovascular Thrombectomy
Other Study IDs
  • PROMOTE-EVT
NCT ID Number
NCT07042490
Start Date (Actual)
2025-06-30
Last Update Posted
2025-06-29
Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Acute ischemic stroke
Plasma adsorption
Endovascular Thrombectomy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPlasma adsorption+Endovascular Thrombectomy
Patients are received plasma adsorption and endovascular thrombectomy.Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days.
Plasma adsorption
Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days.
Endovascular Thrombectomy
The patients will be treated with endovascular thrombectomy.
Active ComparatorEndovascular Thrombectomy
The patients will be treated with endovascular thrombectomy .
Endovascular Thrombectomy
The patients will be treated with endovascular thrombectomy.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
90±7 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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).
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.
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.
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.
72 hours, 7 days
Final infarct volume
Final infarct volume measured with diffusion weighted imaging (DWI) MRI.
7 days (or discharge)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age 18-80 years, male or female.
  2. 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).
  3. Baseline NIHSS after EVT ≥ 6 and ≤25 points.
  4. Randomization and the first plasma adsorption can be initiated within 12 hours after EVT.
  5. Pre-stroke mRS≤ 2 points.
  6. Patient/legally family members have signed the Informed consent form.

  1. Imaging after EVT indicated malignant brain edema with midline shift or brain herniation and surgical treatment was planned.
  2. Parenchymal hemorrhage type 1, or type 2 confirmed by CT.
  3. Allergic to any ingredient of the plasma separator, the adsorption device, or the piping.
  4. 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.
  5. Previous history of malignant tumors, autoimmune diseases or being treated with immunosuppressants, hormones, or tumor necrosis factor inhibitors.
  6. Previous history of organic heart disease and NYHA Class III or IV.
  7. 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).
  8. 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)）.
  9. Pregnancy , lactation or life expectancy of less than 3 months or inability to complete the study for other reasons.
  10. Unwilling to be followed up or poor compliance.
  11. Current or past participation in other clinical research, or participation in this study within 3 months prior to admission.
  12. Other conditions that the researchers think make the patient unsuitable for the study.
Yi Yang logoYi Yang
Study Responsible Party
Yi Yang, Sponsor-Investigator, Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University
Study Central Contact
Contact: Yi Yang, 0086-13756661217, [email protected]
1 Study Locations in 1 Countries

Jilin

The First Hospital of Jilin University, Changchun, Jilin, 130000, China
Yi Yang, MD,PhD, Contact, 0086-13756661217, [email protected]