Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT06265051
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years old;
2. NIHSS score: 6-30;
3. Symptom onset to random time of 24h, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance.
4. mRS 0-1 before the stroke;
5. Subject or legal representative can sign an informed consent form;
6. Clinical symptoms caused by acute occlusion of the following sites confirmed by CTA or MRA: intracranial segment of ICA, M1 segment of middle cerebral artery, M2 trunk of middle cerebral artery;
7. ASPECTS≥6 on NCCT or DWI;
8. After the end of mechanical thrombectomy, the mTICI was stable at 2b/3, and there was no secondary embolism in other non-offending vessels, or the diagnostic angiography before mechanical thrombectomy showed that the occluded vessels improved to mTICI 2b/3, and no mechanical thrombectomy was planned.
Exclusion Criteria:
1. Intra-arterial thrombolysis;
2. Tirofiban was used within 24 hours before endovascular treatment
3. Women who are known to be pregnant or lactating, or have a positive pregnancy test before randomization;
4. Allergy to tirofiban, radiocontrast agent or Nitinol materials;
5. Any active bleeding within 30 days before stroke or recent bleeding (gastrointestinal, urinary, etc.);
6. parenchymal organ surgery or biopsy within 14 days before stroke;
7. History of heparin-induced thrombocytopenia;
8. Platelet count \< 100\*10\^9/L;
9. Being on hemodialysis or peritoneal dialysis; Known severe renal insufficiency (glomerular filtration rate \< 30ml/min or serum creatinine \> 220μmol/L).
10. Subjects requiring hemodialysis or peritoneal dialysis or who have contraindications to angiography for any reason;
11. The expected survival time is less than half a year (such as malignant tumors, serious heart and lung diseases, etc.);
12. Have participated in other interventional clinical studies that may have an impact on the outcome assessment;
13. Other circumstances that the investigator considers inappropriate for participation in the study or that may pose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorder).
14. The midline shift of the brain or cerebral hernia, ventricular mass effect;
15. Acute intracranial hemorrhage on CT or MRI;
16. New bilateral acute stroke or intracranial multi-drainage large vessel occlusion;
17. Simple extracranial occlusion of the internal carotid artery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06265051
Study Brief:
Protocol Section:
NCT06265051