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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01054560
Eligibility Criteria:
Inclusion Criteria:
* Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
* Age22-85
* Clinical signs consistent with acute ischemic stroke
* National Institutes of Health Stroke Scale (NIHSS) ≥8and\<30
* Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of middle cerebral artery, internal carotid artery, basilar or vertebral arteries confirmed by angiography that is accessible to the SOLITAIRETM or MERCI® Device
* Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCI® Device.
* Patient who is ineligible or failed intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice.
* Patient is willing to conduct follow-up visits
Exclusion Criteria:
* NIHSS \> 30 or coma
* Neurological signs that are rapidly improving prior to or at time of treatment
* Females who are pregnant or lactating
* Known serious sensitivity to radiographic contrast agents
* Current participation in another investigation drug or device study
* Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication
* Use of warfarin anticoagulation with International Normalized Ratio (INR) \> 3.0
* Platelet count \< 30,000
* Glucose \< 50 mg/dL
* Arterial tortuosity that would prevent the device from reaching the target vessel
* Life expectancy of less than 90 days
* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
* CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, \>100 cc of tissue) on presentation
* CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
* Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT01054560
Study Brief:
Protocol Section:
NCT01054560