LOTUS: Global Acute Stroke Study Utilizing Penumbra System

NCT04157270 | Terminated FDA Device

• 1 other identifier: CLP 14788
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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

Keywords

Large Vessel Occlusion; LVO; Mechanical Thrombectomy; Penumbra System

Outcome Measures

Primary Outcomes (3)

• mTICI Score

  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.

  Immediate Post Procedure

• Functional Subject Outcome

  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.

  90 days post

• All-cause mortality at 90 days

  All-cause mortality at 90 days

  90 days

Secondary Outcomes (8)

• Safety: Device and procedure related SAE

  Up to 30 days Post Procedure

• Safety: Occurrence of ENT

  Immediate Post Procedure

• Safety: Occurrence of Symptomatic intracranial hemorrhage

  Up to 24 Hours Post Procedure

• Procedural Time

  Immediate Post Procedure

• Stroke Onset to Revascularization

  Immediate Post Procedure

Study Arms (1)

Patients with acute ischemic stroke

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

Device: Penumbra System

Interventions

Penumbra System DEVICE

Penumbra System

Patients with acute ischemic stroke

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify 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 qualify 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (2)

RIA

Englewood, Colorado, 80113, United States

Location

Tampa General Hospital/USF

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: November 8, 2019
• Study Start: January 12, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

US (2)