LOTUS: Global Acute Stroke Study Utilizing Penumbra System

Stroke, Ischemic Clinical Trial

— LOTUS  

Official title:

LOTUS: Global Acute Stroke Study Utilizing Penumbra System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04157270
• Other study ID #: CLP 14788
• Status: Terminated
• Start date: January 12, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: June 2021
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Ischemic

Intervention

Device:
• Penumbra System
Penumbra System

Locations

Country	Name	City	State
United States	RIA	Englewood	Colorado
United States	Tampa General Hospital/USF	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	All-cause mortality at 90 days	All-cause mortality at 90 days	90 days
Secondary	Safety: Device and procedure related SAE	Incidence of device and procedure related Serious Adverse Events (SAEs)	Up to 30 days Post Procedure
Secondary	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
Secondary	Safety: Occurrence of Symptomatic intracranial hemorrhage	Occurrence of symptomatic hemorrhages (sICH) at 24 hours	Up to 24 Hours Post Procedure
Secondary	Procedural Time	Time from the arterial puncture to revascularization defined by mTICI 2b or greater	Immediate Post Procedure
Secondary	Stroke Onset to Revascularization	Time from stroke onset to revascularization defined by mTICI 2b or greater	Immediate Post Procedure
Secondary	Complete Revascularization	Complete revascularization, defined as mTICI 2c and 3	Immediate Post Procedure
Secondary	Length of index hospital stay		Up to 90 days Post Procedure
Secondary	Type of Discharge Facility		Up to 90 days Post Procedure