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临床试验/NCT06289985
NCT06289985招募中不适用

STEP: StrokeNet Thrombectomy Endovascular Platform

Medical University of South Carolina82 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2025年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,600
试验地点
82
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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan Elm

Research Professor-Faculty

Medical University of South Carolina

研究点 (82)

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StrokeNet Thrombectomy Endovascular Platform | 临床试验