Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Penumbra Inc.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient age ≥ 18 and ≤ 85
Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
Planned frontline treatment with aspiration utilizing Penumbra System
Present with symptoms consistent with an acute ischemic stroke within 8 hours of stroke symptom onset
National Institute of Health Stroke Scale (NIHSS) ≥ 6
Signed informed consent per Institution Review Board/Ethics Committee
CT ASPECT score from 6 to 10 (≥ 6) or according to MR DWI ASPECT score from 5 to 10 (≥ 5)
Pre-stroke mRS 0-1
You may not be if
Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
Associated myocardial infarction or severe infection (endocarditis or sepsis)
Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) or \> 3.0 or platelets count \< 40 x 10\^9/L or PTT/APTT \> 50 sec
Uncontrolled hypertension (defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg)
Baseline glucose \< 2.7 or \> 22.2 mmol/L
Seizure at the onset of stroke
Time of stroke symptom onset unknown
Females who are pregnant
Known serious sensitivity to radiographic contrast media that cannot be pre-treated
Renal failure as defined by serum creatinine \> 3.0mg/dl (264 µmol/L)
Currently participating in an investigational (drug, device, etc.) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
CT/MRI evidence of the following conditions at screening: significant mass effect with midline shift, evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM), or intracranial tumor
. Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
Angiographic evidence of occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories
Excessive arterial tortuosity that would prevent the device from reaching the target vessel
Clareo Health | LOTUS: Global Acute Stroke Study Utilizing Penumbra System
