LOTUS: Global Acute Stroke Study Utilizing Penumbra System (LOTUS)

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).

Study Overview

• Status: Terminated
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: Penumbra System

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • RIA
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital/USF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with acute ischemic stroke; Patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO)	Device: Penumbra System; Penumbra System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 90 days	All-cause mortality at 90 days	90 days
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Device and procedure related SAE	Incidence of device and procedure related Serious Adverse Events (SAEs)	Up to 30 days Post Procedure
Safety: Occurrence of ENT	Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure	Immediate Post Procedure
Safety: Occurrence of Symptomatic intracranial hemorrhage	Occurrence of symptomatic hemorrhages (sICH) at 24 hours	Up to 24 Hours Post Procedure
Procedural Time	Time from the arterial puncture to revascularization defined by mTICI 2b or greater	Immediate Post Procedure
Stroke Onset to Revascularization	Time from stroke onset to revascularization defined by mTICI 2b or greater	Immediate Post Procedure
Complete Revascularization	Complete revascularization, defined as mTICI 2c and 3	Immediate Post Procedure
Length of index hospital stay		Up to 90 days Post Procedure
Type of Discharge Facility		Up to 90 days Post Procedure

Collaborators and Investigators

• Sponsor: Penumbra Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2020
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Large Vessel Occlusion; Penumbra System; Mechanical Thrombectomy; LVO
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CLP 14788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes