LOTUS: Global Acute Stroke Study Utilizing Penumbra System
Study Details
Study Description
Brief Summary
The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with acute ischemic stroke Patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) |
Device: Penumbra System
Penumbra System
|
Outcome Measures
Primary Outcome Measures
- mTICI Score [Immediate Post Procedure]
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score of 2b or higher. mTICI scale ranges from 0 to 3 with higher values representing better outcomes.
- Functional Subject Outcome [90 days post]
Good functional subject outcome at 90 days post-procedure as defined by modified Rankin Scale (mRS) 0-2. mRS scale from from 0 to 6 with higher values representing a worse outcome.
- All-cause mortality at 90 days [90 days]
All-cause mortality at 90 days
Secondary Outcome Measures
- Safety: Device and procedure related SAE [Up to 30 days Post Procedure]
Incidence of device and procedure related Serious Adverse Events (SAEs)
- Safety: Occurrence of ENT [Immediate Post Procedure]
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
- Safety: Occurrence of Symptomatic intracranial hemorrhage [Up to 24 Hours Post Procedure]
Occurrence of symptomatic hemorrhages (sICH) at 24 hours
- Procedural Time [Immediate Post Procedure]
Time from the arterial puncture to revascularization defined by mTICI 2b or greater
- Stroke Onset to Revascularization [Immediate Post Procedure]
Time from stroke onset to revascularization defined by mTICI 2b or greater
- Complete Revascularization [Immediate Post Procedure]
Complete revascularization, defined as mTICI 2c and 3
- Length of index hospital stay [Up to 90 days Post Procedure]
- Type of Discharge Facility [Up to 90 days Post Procedure]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient age ≥ 18 and ≤ 85
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Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
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Planned frontline treatment with aspiration utilizing Penumbra System
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Present with symptoms consistent with an acute ischemic stroke within 8 hours of stroke symptom onset
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National Institute of Health Stroke Scale (NIHSS) ≥ 6
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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 (≥
- Pre-stroke mRS 0-1
Exclusion Criteria:
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Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
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Associated myocardial infarction or severe infection (endocarditis or sepsis)
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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
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Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg)
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Baseline glucose < 2.7 or > 22.2 mmol/L
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Seizure at the onset of stroke
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Time of stroke symptom onset unknown
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Females who are pregnant
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Known serious sensitivity to radiographic contrast media that cannot be pre-treated
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Renal failure as defined by serum creatinine > 3.0mg/dl (264 µmol/L)
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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
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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
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. Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
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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
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Excessive arterial tortuosity that would prevent the device from reaching the target vessel
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | RIA | Englewood | Colorado | United States | 80113 |
| 2 | Tampa General Hospital/USF | Tampa | Florida | United States | 33606 |
Sponsors and Collaborators
- Penumbra Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLP 14788