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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06485427
Eligibility Criteria:
Inclusion Criteria
1. Age ≥ 18 and ≤ 80.
2. Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
3. NIHSS score obtained prior to randomization ≥ 6 and ≤ 25.
4. Modified Rankin Scale ≤ 1 prior to qualifying stroke.
5. Arterial puncture performed within 24 hours from symptom onset or LKW.
6. For the patients with symptom onset within 6 hours, the ASPECT score ≥ 6; for the patients with onset within 6-24 hours, the therapy should meet the imaging criteria of DAWN or DEFUSE-3 trial.
7. Patient/Legally Authorized Representative has signed the Informed Consent Form.
Exclusion Criteria
1. Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
2. Baseline CT/MRI confirms the presence of arterial dissection.
3. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
4. Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
5. Severe infection (e.g. sepsis) or multiple organ failure.
6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR \> 3. Patients on factor Xa inhibitor for 48 hours ago must have a normal APTT.
7. Baseline platelet count \< 50 × 10\^9/L.
8. Blood glucose concentration\<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
9. Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg).
10. Previous NHYA\>1.
11. Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
12. Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate \< 30 mL/min or serum creatinine \>220 mmol/L (2.5 mg/dL).
13. Known intracranial aneurysm, and cerebral arteriovenous malformation.
14. Malignant brain tumor or CNS infection.
15. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
16. Female who is pregnant or lactating at time of admission.
17. Anticipated life expectancy \< 6 months.
18. Current participation in another investigational drug or device study.
19. For other reasons, the responsible clinicians believe that the patient is not suitable for continued treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06485427
Study Brief:
Protocol Section:
NCT06485427