NCT06289985 StrokeNet Thrombectomy Endovascular Platform
| NCT ID | NCT06289985 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,600 participants in total. It began in 2025-01-31 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jordan J Elm, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06289985 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06289985 currently recruiting?
Yes, NCT06289985 is actively recruiting participants. Contact the research team at elmj@musc.edu for enrollment information.
Where is the NCT06289985 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06289985 clinical trial?
NCT06289985 is sponsored by Medical University of South Carolina. The principal investigator is Jordan J Elm, PhD at Medical University of South Carolina. The trial plans to enroll 1,600 participants.
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