StrokeNet Thrombectomy Endovascular Platform

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).

Conditions

• Ischemic Stroke

Interventions

OTHER

Medical Management

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

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)

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of Cincinnati

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Berry Consultants

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• MOUNT SINAI HOSPITAL

  collaborator OTHER

• The Cooper Health System

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Stony Brook University

  collaborator OTHER

• University at Buffalo

  collaborator OTHER

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Jordan J Elm, PhD · Medical University of South Carolina

• Eva A Mistry, MBBS, MSCI · University of Cincinnati

• Pooja Khatri, MD · University of Cincinnati

• Colin P Derdeyn, MD · University of Virginia

• Jeffery L Saver, MD · University of California, Los Angeles

• Tudor G Jovin, MD · The Cooper Health System

• Raul G Nogueira, MD, FAHA · University of Pittsburgh

• David Fiorella, MD, PhD · Stony Brook University

• Adnan Siddiqui, MD, PhD · University at Buffalo

• J Mocco, MD, MS · MOUNT SINAI HOSPITAL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2029-01-31

Completion

2030-01-31

FDA Device

Yes

Countries

• United States

Study Locations