Ischemic Stroke
Conditions
Brief summary
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO).
Detailed description
The StrokeNet Thrombectomy Endovascular Platform (STEP) is conducted within NIH StrokeNet at 38 comprehensive stroke centers across the US. The primary goal is to optimize all aspects of care of acute ischemic stroke patients with a large or a medium vessel occlusion. The platform trial operates under an overarching Master Protocol in an inferentially integrated framework. The platform trial is designed to support the studies of three broad categories of therapeutics: expansion of endovascular treatment (EVT) indications, innovative EVT devices and concomitant medical therapies, and novel pre- and early-hospital technologies and systems of care. As new interventions are put forth, they will be added to the Master Protocol as a new Domain or part of an existing Domain. STEP utilizes a flexible Bayesian design with frequent adaptive analyses to assess whether a given intervention is superior, inferior, or equivalent either within a Domain or for specific populations within the Domain.
Interventions
DEVICEEndovascular thrombectomy with any FDA-approved category POL or NRY device
Endovascular thrombectomy with any FDA-approved category POL or NRY device - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL), and/or Catheter, Thrombus Retriever (NRY)
OTHERMedical Management
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
University of Virginia
Berry Consultants
University of California, Los Angeles
MOUNT SINAI HOSPITAL
The Cooper Health System
University of Pittsburgh Medical Center
Stony Brook University
University at Buffalo
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
STEP PLATFORM INCLUSION CRITERIA: 1. Suspected diagnosis acute ischemic stroke 2. Likely causative intracranial large or medium vessel occlusion STEP PLATFORM
Exclusion criteria
1. Proven contraindication to endovascular thrombectomy 2. Prisoners/incarcerated DOMAIN-SPECIFIC ELIGIBILITY CRITERIA: Each domain may have additional eligibility criteria. STEP EVT INDICATION EXPANSION DOMAIN INCLUSION CRITERIA: 1\. Age 18 years or older 2. Pre-stroke modified Rankin Scale score 0-2 3. Presentation to enrolling hospital within 24 hours of last known well/stroke onset 4. Able to initiate arterial puncture within 2 hours from qualifying CTA/MRA or CTP/MRP imaging \*CT/MR and qualifying CTA/MRA or CTP/MRP should be repeated if more than 120 minutes have elapsed since the imaging and randomization has not been performed. The exception is for LVO Mild deficit/Low NIHSS 0-5 for which imaging would only need to be repeated if there has been significant improvement in the NIHSS prior to randomization. 5\. Has one of the following presentations: 1. LVO patients with mild deficits/low NIHSS (must have both): 1. Mild presenting neurologic deficits - NIHSS 0-5 (Must have some focal neurological deficit attributable to the target occlusion if NIHSS 0) 2. Complete occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA) 2. Medium/Distal Vessel Occlusion: 1. Visualized complete occlusion or perfusion deficit (Tmax \> 4s) supportive of a cortical branch occlusion in one of the following vessels: i) Non-dominant/Co-dominant M2 (defined as serving \< 50% of entire overall MCA territory) ii) M3 2. If symptom onset is \> 6h, the core must be less than 50% of the territory supplied by the occluded vessel as evident by either: i) Hypodensity and loss of grey-white border on NCCT or ii)ADC \<620 mm2/s on diffusion MRI or rCBF\<30% on CTP 3. NIHSS \> =8 STEP EVT INDICATION EXPANSION DOMAIN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global disability measured by Modified Rankin Score | 90-day | The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead. The analysis of the primary endpoint will be based on a utility weighting of the 7 outcomes, where 0 represents the worst possible health state and 1 represents the best possible state. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global disability measured by Modified Rankin Score | 1 day of hospital discharge | The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead. |
| Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS) | 24 (+/-12) hours after the time of randomization | NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke. |
| Symptomatic intracranial hemorrhage | 36 hours after randomization | modified Heidelberg definition |
| Any radiologic intracranial hemorrhage | 36 hours after randomization | any acute intracranial blood, symptomatic or asymptomatic |
| Mortality | 90 days | all cause deaths |
Countries
United States
Contacts
Primary ContactJordan Elm
Outcome results
None listed