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Optimizing care for patients with acute ischemic stroke

STEP: StrokeNet Thrombectomy Endovascular Platform

Not applicable Interventional Medical University of South Carolina · NCT06289985

This study is testing different treatments for people who have had a stroke caused by blocked blood vessels to see which ones work best.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1600 (estimated)
Ages18 Years and up
SexAll
SponsorMedical University of South Carolina Academic / other
Locations41 sites (Birmingham, Alabama and 40 other locations)
Trial IDNCT06289985 on ClinicalTrials.gov

What this trial studies

The StrokeNet Thrombectomy Endovascular Platform (STEP) is a randomized, multifactorial, adaptive platform trial aimed at improving the treatment of patients suffering from acute ischemic stroke caused by large or medium vessel occlusions. Conducted at 38 comprehensive stroke centers across the US, the trial employs a flexible Bayesian design to evaluate various therapeutic interventions, including endovascular thrombectomy and innovative medical therapies. As new treatments are developed, they can be integrated into the existing framework, allowing for continuous optimization of patient care. The trial's adaptive nature enables real-time assessments of intervention effectiveness within specific patient populations.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with suspected acute ischemic stroke and likely large or medium vessel occlusions.

Not a fit: Patients with proven contraindications to endovascular thrombectomy or those who are incarcerated may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly enhance treatment outcomes for patients experiencing acute ischemic strokes.

How similar studies have performed: Other studies utilizing adaptive platform trial designs have shown promise in optimizing treatment strategies, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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
   10. Known or high suspicion for underlying intracranial atherosclerotic disease (ICAD)
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. Tandem occlusions
   5. Significant mass effect with midline shift (\>5mm)
   6. Evidence of intra-cranial tumor (except small meningioma defined as (1) \<=3 cm, (2) asymptomatic) as confirmed on CT/MRI)
   7. Evidence of acute intracranial hemorrhage

Where this trial is running

Birmingham, Alabama and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic Stroke
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.