Clinical trial NCT04157270: LOTUS: Global Acute Stroke Study Utilizing Penumbra System
Official title: LOTUS: Global Acute Stroke Study Utilizing Penumbra System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke, Ischemic
Keywords: Large Vessel Occlusion
LVO
Mechanical Thrombectomy
Penumbra System
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: mTICI Score
timeFrame: Immediate Post Procedure
measure: Functional Subject Outcome
timeFrame: 90 days post
measure: All-cause mortality at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Safety: Device and procedure related SAE
timeFrame: Up to 30 days Post Procedure
measure: Safety: Occurrence of ENT
timeFrame: Immediate Post Procedure
measure: Safety: Occurrence of Symptomatic intracranial hemorrhage
timeFrame: Up to 24 Hours Post Procedure
measure: Procedural Time
timeFrame: Immediate Post Procedure
measure: Stroke Onset to Revascularization
timeFrame: Immediate Post Procedure
measure: Complete Revascularization
timeFrame: Immediate Post Procedure
measure: Length of index hospital stay
timeFrame: Up to 90 days Post Procedure
measure: Type of Discharge Facility
timeFrame: Up to 90 days Post Procedure
Other outcomes:
Locations:
city: Englewood
country: United States
facility: RIA
state: Colorado
city: Tampa
country: United States
facility: Tampa General Hospital/USF
state: Florida
Study officials:
References: