No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
1,600 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for people who have had a suspected ischemic stroke due to a blockage in a large or medium blood vessel in the brain. Participants will be assessed to determine if they can receive a treatment called endovascular thrombectomy.
Are You a Good Fit for This Trial?
You may be able to join if
I have a suspected diagnosis of acute ischemic stroke.
I likely have a blockage in a large or medium blood vessel in my brain.
I am 18 years old or older.
My stroke symptoms started within the last 24 hours.
I can start the procedure within 2 hours after imaging.
I have mild neurological deficits with specific scores.
I have a complete blockage of a major brain artery.
You may not be able to join if
I cannot have endovascular thrombectomy for medical reasons.
I am currently in prison.
I have a known severe allergic reaction to contrast material.
I am pregnant.
I have serious health problems that may affect my treatment outcome.
I have evidence of a significant stroke complication.
I have known chronic conditions affecting my blood vessels.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Status
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 CRITERI…
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
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