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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT01270867
Eligibility Criteria:
Key Inclusion Criteria:
* Patient presenting with clinical signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, and:
* Patient has failed IV t-PA therapy Or
* Patient is contraindicated for IV t-PA administration
* NIHSS 8 \< NIHSS \< 29
* Anticipated life expectancy of at least 6 months
* No significant pre-stroke disability (mRS \< 1)
* Written informed consent to participate given by patient or legal representative
* Angiographic confirmation of a persistent large vessel occlusion in the internal carotid, middle cerebral (M1 and/or M2 segments), basilar and/or vertebral arteries
* Treatable within 8 hours of symptom onset, defined as the first pass being made with the assigned study device
Key Exclusion Criteria:
* Abnormal blood pressure and/or blood coagulation lab values
* Pregnancy
* Patient participating in another investigational drug or device study
* More than 1/3 of MCA or equivalent in non-MCA territory
* Baseline evidence of significant mass effect with midline shift, or hemorrhage, or intracranial tumor
* Bilateral stroke
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01270867
Study Brief:
Protocol Section:
NCT01270867