Clinical trial NCT06289985: StrokeNet Thrombectomy Endovascular Platform
Official title: STEP: StrokeNet Thrombectomy Endovascular Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Cincinnati
name: University of Virginia
name: Berry Consultants
name: University of California, Los Angeles
name: MOUNT SINAI HOSPITAL
name: The Cooper Health System
name: University of Pittsburgh Medical Center
name: Stony Brook University
name: University at Buffalo
First posted: 2024-03-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains.
Primary purpose: TREATMENT

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.

Eligibility 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. 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
   2. Occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)
2. Medium/Distal Vessel Occlusion (must have all 4):

   1. Visualized occlusion or perfusion deficit supportive of a cortical branch occlusion (10 cc volume of Tmax \>4s) in one of the following vessels: i) Non-dominant/Co-dominant M2 (defined as serving \< 50% of entire overall MCA territory) ii) M3 iii) M4 iv) A1 v) A2 vi) A3 vii) P1 viii) P2 ix) P3
   2. Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on NCCT or ADC \<620 mm2/s on diffusion MRI or rCBF\<30% on CTP after 6h of symptom onset.
   3. NIHSS \> 4 or NIHSS 2-3 with clearly disabling deficits at presentation to enrolling hospital
   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.

STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:

1. Clinical

   1. Presumed septic embolus; suspicion of bacterial endocarditis
   2. Seizure at stroke onset or between onset and enrollment
   3. Known anaphylactic reaction to contrast material that precludes endovascular reperfusion therapy
   4. Intracranial occlusion suspected to be chronic, based on history and/or imaging
   5. Intracranial dissection, based on history and/or imaging
   6. Cerebral vasculitis, based on history and/or imaging
   7. Known pregnancy
   8. Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
   9. Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment
2. Laboratory

   a. Known platelet count \<100,000/uL
3. Imaging

   1. CT ASPECT score \<6 (MRI ASPECT score \<7)
   2. Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy.
   3. Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
   4. Significant mass effect with midline shift (\>5mm)
   5. Evidence of intra-axial tumor (except small meningioma)
   6. Evidence of acute intracranial hemorrhage

Primary outcomes:
measure: Global disability measured by Modified Rankin Score
timeFrame: 90-day
Secondary outcomes:
Other outcomes:
measure: Global disability measured by Modified Rankin Score
timeFrame: 1 day of hospital discharge
measure: Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 (+/-12) hours after the time of randomization
measure: Symptomatic intracranial hemorrhage
timeFrame: 36 hours after randomization
measure: Any radiologic intracranial hemorrhage
timeFrame: 36 hours after randomization
measure: Mortality
timeFrame: 90 days
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: La Jolla
country: United States
facility: UCSD Health La Jolla
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Edina
country: United States
facility: M Health Fairview Southdale Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center
state: Minnesota
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Hospital
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: OSU Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Mercy Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina University Hospital
state: South Carolina
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Plano
country: United States
facility: Medical City Plano
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Healthcare
state: Utah
city: Charlottesville
country: United States
facility: UVA Medical Center
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Medical University of South Carolina
name: Jordan J Elm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Eva A Mistry, MBBS, MSCI
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Pooja Khatri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Colin P Derdeyn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Jeffery L Saver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cooper Health System
name: Tudor G Jovin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Raul G Nogueira, MD, FAHA
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook University
name: David Fiorella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Adnan Siddiqui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: J Mocco, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: