NCT06289985 · Medical University of South Carolina
StrokeNet Thrombectomy Endovascular Platform
(STEP)
What this study is about
STEP is a randomly assigned, 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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Suspected diagnosis acute ischemic stroke
- Likely causative intracranial large or medium vessel occlusion STEP PLATFORM
Exclusion criteria
- Proven contraindication to endovascular thrombectomy
- 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:
- LVO patients with mild deficits/low NIHSS (must have both):
- Mild presenting neurologic deficits - NIHSS 0-5 (Must have some focal neurological deficit attributable to the target occlusion if NIHSS 0)
- Complete occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)
- Medium/Distal Vessel Occlusion:
- 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
- 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
- NIHSS \> =8 STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:
- Presumed septic embolus; suspicion of bacterial endocarditis
- Seizure at stroke onset or between onset and enrollment
- Known anaphylactic reaction to contrast material that precludes endovascular reperfusion therapy
- Intracranial occlusion suspected to be chronic, based on history and/or imaging
- Intracranial dissection, based on history and/or imaging
- Cerebral vasculitis, based on history and/or imaging
- Known pregnancy
- Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
- Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment
- Known or high suspicion for underlying intracranial atherosclerotic disease (ICAD)
- Laboratory a. Known platelet count \<100,000/uL
- CT ASPECT score \<6 (MRI ASPECT score \<7)
- Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy.
- Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
- Tandem occlusions
- Significant mass effect with midline shift (\>5mm)
- Evidence of intra-cranial tumor (except small meningioma defined as (1) \<=3 cm, (2) asymptomatic) as confirmed on CT/MRI)
- Evidence of acute intracranial hemorrhage
Where
- Birmingham, Alabama
- La Jolla, California
- Los Angeles, California
- San Diego, California
- Stanford, California
- Hartford, Connecticut
- New Haven, Connecticut
- Miami, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Iowa City, Iowa
And 25 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations