Clinical trial NCT04801225: Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients
Official title: Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Stroke
Lead sponsor: Nervive, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Early Feasibility Study (EFS) is a multi-center, open-label single-arm study in 10 acute ischemic stroke (AIS) patients treated with VitalFlow-IS stimulation within 6 hours of symptom onset. The purpose of the EFS is to evaluate initial clinical safety and device functionality in the clinical workflow setting for treatment of acute ischemic stroke patients that will inform design modifications and/or user interface in preparation for next steps consisting of (1) a full safety/feasibility clinical study and (2) randomized controlled pivotal trial with a surrogate endpoint (expedited Premarket Approval (PMA) pathway).


Eligibility criteria: Inclusion Criteria:

* Time last known normal within 4.5 hours of presentation for enrollment

  * Allows 1.5 hours for pre-stimulation study procedures to maintain a 6-hour therapeutic window
  * IV rtPA and Endovascular Treatment (EVT) permissible if not inappropriately delayed by study procedures
* Age 18-85 years
* Diagnosis of ischemic stroke in the anterior circulation
* NIHSS at baseline 4-20
* Creatinine \< 1.7 mg/dL
* Signed informed consent by patient/Legally Authorized Representative (LAR)

Exclusion Criteria:

* Pre-stroke disability Modified Rankin Score (mRS) between 2-6
* Inability to communicate sufficiently to participate in study procedures
* Neuroimaging with intracranial hemorrhage, severe brain edema, or ASPECTS \<5
* Known or newly-discovered aneurysm or arteriovenous malformation (AVM)
* Intracranial mass lesion, infection, or other reason to suspect increased intracranial pressure
* Metallic foreign bodies or implanted devices in the head or neck, including tattoos
* Cardiac, vagal nerve, or intracranial neural stimulation device
* Cochlear implant or implanted hearing aid
* Potential for delay in intravenous rtPA or endovascular therapy due to study procedures

  * Intravenous (IV) rtPA: Stimulation might be delivered during the rtPA infusion period
  * EVT: Stimulation might be performed while EVT team is mobilized
* Seizure concurrent to stroke, or history of seizures, epilepsy, or recurrent syncopal events.
* History of neuropathy (including facial nerve injury), carotid surgery, or vagotomy.

Primary outcomes:
measure: Rate of device-related adverse events
timeFrame: 90 days post-procedure
measure: Feasibility of device use in the Clinical Environment as assessed by User Survey
timeFrame: 1-7 days post-procedure
Secondary outcomes:
measure: Exploratory - Rate of change in core volume as measured by Computed Tomography Perfusion
timeFrame: 2-4 hours post-procedure
measure: Exploratory - Rate of change in penumbra volume as measured by Computed Tomography Perfusion
timeFrame: 2-4 hours post-procedure
measure: Exploratory - Rate of change in collateral blood flow as measured by Computed Tomography Perfusion
timeFrame: 2-4 hours post-procedure
measure: Exploratory - Rate of change in occlusion status as measured by Computed Tomography Perfusion
timeFrame: 2-4 hours post-procedure
measure: Exploratory - Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume
timeFrame: 24 hours post-procedure
measure: Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - short-term
timeFrame: Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure
measure: Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - 24 hours
timeFrame: 24 hours post-procedure
measure: Exploratory - Patient Outcome as determined by National Institute of Health Stroke Scale (NIHSS)
timeFrame: 90 days post-procedure
measure: Exploratory - Patient Outcome as determined by Modified Rankin Scale (mRS)
timeFrame: 90 days post-procedure
measure: Exploratory - Final change in infarct growth - CTP (CBF<30%) at pre-stimulation vs MRI-DWI lesion at 24 hours
timeFrame: 24 hours post-procedure
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: Nervive, Inc.
name: Stephanie Harrington, MS
role: STUDY_DIRECTOR
affiliation: Nervive, Inc.
name: Emilio Sacristan, PhD
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Ken Uchino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MetroHealth System, Ohio
name: Jon Schrock, MD
role: PRINCIPAL_INVESTIGATOR
References: