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Rescue endovascular therapy for progressive acute mild ischemic stroke with large vascular occlusion

Rescue endovascular therapy for progressive acute mild ischemic stroke with large vascular occlusion--- A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079561
Enrollment
Unknown
Registered
2024-01-05
Start date
2024-01-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with the anterior circulation and a minor stroke who experienced an END and LVO

Interventions

EVT:endovascular treatment
BMT:medical treatment

Sponsors

Yijishan Hospital of Wannan Medical college
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: General Inclusion Criteria: (1) Age >= 18 years old; (2) The initial onset of the disease is consistent with the diagnosis of mild ischemic stroke, with a NIHSS score of less than 6; (3) Symptom progression: During progression, the NIHSS score increases by >= 4 points compared to the initial NIHSS score; (4) The progression time of symptoms is within 7 days of the first onset; (5) The time from initial onset to randomization is greater than 24 hours; The first onset includes wake up stroke; The onset time refers to the patient's last known well (LKW); (6) Symptoms progress to randomization time = 6 points before randomization; (8) The patient or legal representative is willing to comply with the protocol requirements and data collection procedures, understand and sign the informed consent form. Specific Neuroimaging Inclusion Criteria: (1) CTA or MRA proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery; (2) The progression of symptoms is caused by the recurrence of cerebrovascular diseases in the same vascular region, or the pathogenesis is caused by reduced blood flow perfusion; (3) NCCT ASPECTS before randomization = 6; (4) CTP or MRP assessment shows low perfusion in the target vessel area, and meets the following criteria: core infarction volume is less than 50ml, mismatch rate is greater than or equal to 1.8, and mismatch volume is greater than 15ml.

Exclusion criteria

Exclusion criteria: 1. Pre-stroke mRS score >1; 2. Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes; 3. The target vessel may have factors that may prevent it from completing endovascular treatment, such as a diameter less than 1.5mm, a tortuous vascular pathway, difficulty in reaching the target position with instruments, or difficulty in recovery; 4. Severe stenosis or occlusion of multiple blood vessels; 5. Combined with untreated intracranial aneurysms, intracranial tumors (excluding small meningiomas), or intracranial vascular malformations; 6. Intracranial hemorrhage within 6 months, including cerebral parenchymal hemorrhage, ventricular hemorrhage, and subarachnoid hemorrhage; 7. Have had gastrointestinal or urinary system bleeding, acute myocardial infarction, traumatic brain injury, or undergone major surgical procedures within the past month; 8. Known hemorrhagic tendency (including but not limited to): Baseline platelet count 2 (Patients with no history or suspected coagulopathy do not need to wait for laboratory results of INR or APTT prior to enrollment); 9. Severe heart, liver, kidney function damage or other severe late stage diseases of the system; 10. Known allergies to treatment related drugs such as iodine contrast agents, etc; 11. Known severe allergy (more than a rash) to contrast media uncontrolled by medications; 12. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg); 13. Uncontrolled blood sugar abnormalities (less than 2.8mmol/l or greater than 22.2mmol/l); 14. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test; 15. The expected survival time is less than 1 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.) ? Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial; 16. Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders);

Design outcomes

Primary

MeasureTime frame
favorable outcome mRS0-2;symptomatic intracerebral haemorrhage;

Secondary

MeasureTime frame
mRS shift analysis;outcome mRS0-3;EQ-5D-5L score;The infarct-core volume;mortality;any intracerebral haemorrhage;favorable outcome mRS0-2;

Countries

China

Contacts

Public ContactZhiming Zhou

Yijishan Hospital of Wannan Medical college

zhouzhiming@yjsyy.com+86 553 5739543

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026