STEP: StrokeNet Thrombectomy Endovascular Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 61
- 主要终点
- Global disability measured by Modified Rankin Score
研究概览
简要总结
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).
详细描述
The StrokeNet Thrombectomy Endovascular Platform (STEP) is conducted within NIH StrokeNet at 38 comprehensive stroke centers across the US. The primary goal is to optimize all aspects of care of acute ischemic stroke patients with a large or a medium vessel occlusion. The platform trial operates under an overarching Master Protocol in an inferentially integrated framework. The platform trial is designed to support the studies of three broad categories of therapeutics: expansion of endovascular treatment (EVT) indications, innovative EVT devices and concomitant medical therapies, and novel pre- and early-hospital technologies and systems of care. As new interventions are put forth, they will be added to the Master Protocol as a new Domain or part of an existing Domain. STEP utilizes a flexible Bayesian design with frequent adaptive analyses to assess whether a given intervention is superior, inferior, or equivalent either within a Domain or for specific populations within the Domain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEP PLATFORM INCLUSION CRITERIA:
- •Suspected diagnosis acute ischemic stroke
- •Likely causative intracranial large or medium vessel occlusion
- •STEP PLATFORM
排除标准
- •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
- •Pre-stroke modified Rankin Scale score 0-2
- •Presentation to enrolling hospital within 24 hours of last known well/stroke onset
- •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:
- •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
- •STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:
- •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)
- •a. Known platelet count <100,000/uL
- •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
研究组 & 干预措施
Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata
Adult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies:
- Endovascular Therapy (EVT)
- Medical Management (MM)
干预措施: Endovascular thrombectomy with any FDA-approved category POL or NRY device (Device)
Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata
Adult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies:
- Endovascular Therapy (EVT)
- Medical Management (MM)
干预措施: Medical Management (Other)
Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata
Adult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3 occlusion will be randomized to receive one of two strategies:
- Endovascular Therapy (EVT)
- Medical Management (MM)
干预措施: Endovascular thrombectomy with any FDA-approved category POL or NRY device (Device)
Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata
Adult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3 occlusion will be randomized to receive one of two strategies:
- Endovascular Therapy (EVT)
- Medical Management (MM)
干预措施: Medical Management (Other)
结局指标
主要结局
Global disability measured by Modified Rankin Score
时间窗: 90-day
The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead. The analysis of the primary endpoint will be based on a utility weighting of the 7 outcomes, where 0 represents the worst possible health state and 1 represents the best possible state.
次要结局
未报告次要终点
研究者
Jordan Elm
Research Professor-Faculty
Medical University of South Carolina