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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT04466033
Eligibility Criteria:
Inclusion Criteria:
1. Clinical signs consistent with acute ischemic stroke
2. Patient with Acute Ischemic Stroke within 24 hours from symptoms o
3. Age 18-85 years old
4. Consent process is completed per international and local regulations
Exclusion Criteria:
1. Known use of cocaine or other vasoactive substance
2. Known bleeding diathesis
3. Any known hemorrhagic or coagulation deficiency.
4. Current use of oral anticoagulants with International Normalized Ratio (INR) \> 3;
5. PTT (Partial Thromboplastin Time)\>2 at screening
6. Uncontrolled hypertension (Systolic blood pressure\>185 or Diastolic blood pressure\>110) refractory to pharmacological management
7. Pregnant or lactating female
8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score\<6, mass effect and/or intracranial tumor
9. Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04466033
Study Brief:
Protocol Section:
NCT04466033