Stoke Alert! Newsletter Summer 2021

Neurological Institute

Stroke Alert!

Alert!

Summer 2021

Stroke Month THIS ISSUE SUMMER 2021

• Aneurysms, Strokes, and Carotids Virtual Education Event • Did you know…

• Could this be a stroke?

• EMS Week • We don’t just follow the the standards, we create them

2019

Join us for the Sixth Annual Innovations in Cerebrovascular Science Conference September 16-18, 2021

Ponte Vedra Inn & Club 200 Ponte Vedra Blvd., Ponte Vedra Beach, FL 32082 Thursday, September 16 Registration 7 am Program 7:30 am – 5 pm

Friday, September 17 Registration 7:30 am Program 7:30 am – 6:15 pm

Saturday, September 18 Registration 7:30 am Program 8 am – 4 pm

Learn from international experts in adult and pediatric neuroscience.

Topics will include innovations in: Complex Aneurysm Treatment • Neurocritical Care • Ischemic and Hemorrhagic Stroke • Neuroradiology Cost for attendees: Physicians: $100 • Nurses and other clinicians: $25 • EMS: FREE For more information and to register, please visit lyerlyneuro.com/symposium

Neurological Institute In collaboration with the Stys Neuroscience Institute at Wolfson Children’s Hospital

Did you know…

About

795,000

That means, on average, a stroke occurs every

Americans each year suffer a new or recurrent stroke

Stroke kills more than

137,000 people a year

40 seconds On average, someone dies of stroke every

4 minutes

Stroke deaths occur about

40%and 60%

in males

in females

That’s about out of every deaths

1

18

Could this be a stroke?

A stroke can affect any of us at any time.

You must act quickly!

Stroke symptoms:

B

E

F

A

S

T

Balance

Eyes

Face

Arm (or Leg)

Speech

Time is Brain!!

Is there a sudden loss of balance or coordination?

Is there sudden trouble seeing out of one or both eyes?

Is one side of the face drooping?

Ask the person to smile.

Is an arm or leg numb or weak?

Does the person have sudden trouble speaking or understanding?

Call for help immediately.

If known, take note of when the symptoms began.

If you witness someone having stroke symptoms, please dial 911.

Neurological Institute

EMS Week

Thank you

to all of our first responders and their dedication to the care of our stroke patients.

We don’t just follow the standards, we create them We are pleased to highlight the following clinical trials for this quarter.

Success n

urpose – Assess safety and performance of the Comaneci Embolization Assist Device as a temporary endovascular P device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width < 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as > 4 mm or a dome-to-neck ratio < 2.

Inclusion • Documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils • Treatment with coil embolization assisted by the Comaneci Device for wide-necked intracranial aneurysms with neck width < 10 mm. A wide-necked intracranial aneurysm defined by the neck width as > 4 mm or a dome-to-neck ratio < 2 n

n Exclusion • K nown hypersensitivity to nickel-titanium

Stem n

urpose – to assess the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the P management of Chronic Subdural Hematoma (cSDH).

I nclusion • Male or female subject whose age is > 30 at the time of consent • Pre-morbid mRS 0-1 • cSDH measures > 10 mm in greatest thickness • cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift • Imaging characteristics indicative of chronicity (> 50% of the volume of the collection should be isodense or hypodense to normal cortical gray matter on Computed Tomography (CT)) • Subject presents with one or more of the following neurological symptoms: headache; cognitive decline; speech difficulty or Aphasia; gait impairment or imbalance; focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop); and/or seizure n

Escape-next n

urpose – Determine the efficacy of the neuroprotectant, nerinetide in reducing global disability in participants with P acute ischemic stroke undergoing endovascular thrombectomy excluding thrombolysis. Study arm will be placebo by vehicle only or Nerinetide single intravenous infusion of 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes.

Inclusion • Acute ischemic stroke (AIS) selected for emergency endovascular treatment • Age 18 years or greater • O nset (last-known-well) time to randomization time within 12 hours • Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS): – NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion; or – NIHSS > 10 for M2-MCA occlusion • Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA n

NeVa stent retriever for treatment of LVO strokes n

urpose – to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute P ischemic stroke with the NeVa stent retrievers.

The NeVa device has a large offset opening that allows clot to rapidly incorporate inside the device. It has a balanced design that optimizes radial force balanced with large opening and minimal metal coverage. The device also has a clot capture basket that retains the clot to prevent downstream migration.

Inclusion • Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups: – Subject has failed IV t-PA therapy – Subject is contraindicated for IV t-PA administration – IV-tPA given within 3 hours of symptom onset – Age >18 and less than equal to 85 – NIHSS score > 8 and > 25 – Prestroke mRS score of > 1 – Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA n

Ongoing research summary TIMELESS

PROST

EMBOLIZE

PhaseBio

PERFORMANCE-II

ADVANCE

Study type

Interventional

Interventional

Interventional

Interventional

Interventional

Interventional

Estimate enrollment

456

316

600

200

305

140

Allocation

Randomized

Randomized

Non-Randomized

N/A

N/A

N/A

Intervention Model

Parallel assignment

Parallel assignment

Parallel assignment

Single group assignment

Single group assignment

Single group assignment

Masking

Quadruple

Single (outcome assessor)

None (open label)

None (open label)

None (open label)

None (open label)

Primary purpose

Treatment

Treatment

Treatment

Treatment

Treatment

Treatment

Start date

March 2019

October 2019

September 2019

March 2020

June 2020

April 2020

Estimated primary completion date

November 2021

December 2020 August 2021

December 2023

September 2022

April 2024

For a complete list of all current Baptist Health Research Institute trials please visit baptistjax.com/patient-info/baptist-research-institute/clinical-trials

Neurological Institute

Emergency Transfers: 904.202.BRAIN (2724) Fast-Access Office Appointments: 904.861.0316 Referral Fax: 904.384.1005