LOTUS: Global Acute Stroke Study Utilizing Penumbra System

NCT ID: NCT04157270

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-12
• Study Completion Date: 2021-05-10

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).

Conditions

Stroke, Ischemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with acute ischemic stroke

Patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO)

Penumbra System

Intervention Type: DEVICE

Penumbra System

Interventions

Penumbra System

Penumbra System

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RIA

Englewood, Colorado, United States

Tampa General Hospital/USF

Tampa, Florida, United States

Countries

United States

Other Identifiers

CLP 14788

Identifier Type: -

Identifier Source: org_study_id