LOTUS: Global Acute Stroke Study Utilizing Penumbra System
- Conditions
- Stroke, Ischemic
- Interventions
- Device: Penumbra System
- Registration Number
- NCT04157270
- Lead Sponsor
- Penumbra Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with acute ischemic stroke Penumbra System Patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Symptomatic intracranial hemorrhage Up to 24 Hours Post Procedure Occurrence of symptomatic hemorrhages (sICH) at 24 hours
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
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
Procedural Time Immediate Post Procedure Time from the arterial puncture to revascularization defined by mTICI 2b or greater
Type of Discharge Facility Up to 90 days Post Procedure Length of index hospital stay Up to 90 days Post Procedure
Trial Locations
- Locations (2)
Tampa General Hospital/USF
🇺🇸Tampa, Florida, United States
RIA
🇺🇸Englewood, Colorado, United States