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New treatment option for Ischemic Stroke
Official title StrokeNet Thrombectomy Endovascular Platform
ClinicalTrials.gov ID: NCT06289985
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- STEP PLATFORM
- Suspected diagnosis acute ischemic stroke
- Likely causative intracranial large or medium vessel occlusion STEP PLATFORM
You likely can't join if
- Proven contraindication to endovascular thrombectomy
- Prisoners/incarcerated DOMAIN-SPECIFIC ELIGIBILITY CRITERIA: Each domain may have additional eligibility criteria. STEP EVT INDICATION EXPANSION...
- 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:
See the full eligibility criteria
- STEP PLATFORM
- Suspected diagnosis acute ischemic stroke
- Likely causative intracranial large or medium vessel occlusion STEP PLATFORM
- 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...
- 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...
- 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...
- NIHSS \> =8 STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Stanford, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Edina, Minnesota, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Camden, New Jersey, United States
- Brooklyn, New York, United States
- Buffalo, New York, United States
- New York, New York, United States
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; Los Angeles, California, United States; San Diego, California, United States; Stanford, California, United States; Hartford, Connecticut, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.