RecruitingNot ApplicableNCT06289985
StrokeNet Thrombectomy Endovascular Platform
STEP: StrokeNet Thrombectomy Endovascular Platform
Sponsor
Medical University of South Carolina
Enrollment
1,600 participants
Start Date
Jan 31, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria14
- Suspected diagnosis acute ischemic stroke
- Likely causative intracranial large or medium vessel occlusion
- \. 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.
- \. 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
Exclusion Criteria25
- Proven contraindication to endovascular thrombectomy
- Prisoners/incarcerated
- DOMAIN-SPECIFIC ELIGIBILITY CRITERIA:
- Each domain may have additional eligibility criteria.
- Clinical
- 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
- Imaging
- 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
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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.
Locations(41)
View Full Details on ClinicalTrials.gov
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NCT06289985
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