NCT06289985

StrokeNet Thrombectomy Endovascular Platform

STEP: StrokeNet Thrombectomy Endovascular Platform

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Endovascular 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)
OTHER	Medical Management	Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.

Timeline

• Start date: 2025-01-31
• Primary completion: 2029-01-31
• Completion: 2030-01-31
• First posted: 2024-03-04
• Last updated: 2025-12-04

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated device study