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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT00334061
Eligibility Criteria:
Inclusion Criteria:
* Clinical signs consistent with acute ischemic stroke
* 18 to 79 years of age
* Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \> 8
* TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
* Signed informed consent
* Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.
Exclusion Criteria:
* Evidence of rapidly improving neurological signs of stroke at time of enrollment
* NIHSS \> 30 or coma
* Females who are pregnant
* Vessel tortuosity too difficult to allow endovascular access
* Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) \> 3.0
* Partial thromboplastin time (PTT) greater than 2 times the lab normal
* Admission platelets \< 30,000
* Pre-existing neurological or psychiatric disease that could confound the study results
* Known severe allergy to contrast media
* Uncontrolled hypertension
* Computed tomography (CT) evidence of significant mass effect with a midline shift
* CT reveals evidence of large hypodensity region \> 1/3 of the middle cerebral artery territory
* CT reveals evidence of intracranial hemorrhage
* CT reveals significant mass effect with midline shift
* Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
* Angiographic evidence of preexisting arterial injury
* Life expectancy of less than 90 days
* Participation in another clinical investigation that could confound the evaluation of the study device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT00334061
Study Brief:
Protocol Section:
NCT00334061