Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

Summary

This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.

Conditions

• Stroke, Acute
• Cerebral Infarction

Interventions

PROCEDURE

Endovascular Thrombectomy

Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.

DEVICE

Trevo Retriever

Trevo Retriever is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.

DEVICE

Solitaire™ FR Revascularization Device

Solitaire™ FR Revascularization Device is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.

DEVICE

Penumbra thrombectomy system

Penumbra thrombectomy system is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure. The Penumbra System includes: • Penumbra Aspiration Pump (1115V) Penumbra System 054 Penumbra System MAX Penumbra System 110 Aspiration Tubing Penumbra System \[026, 032, 041\] Penumbra System Separator Flex \[026, 032, 041, 054\] Penumbra Pump MAX Penumbra System Reperfusion Catheter ACE64 \& ACE68

DEVICE

Covidien MindFrame Capture Revascularization Device

Covidien MindFrame Capture Revascularization Device is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of Cincinnati

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• NINDS Stroke Trials Network (StrokeNet)

  collaborator OTHER

• Gregory W Albers

  lead OTHER

Principal Investigators

• Gregory Albers, MD · Stanford University

• Michael Marks, MD · Stanford University

• Maarten Lansberg, MD, PhD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2017-08-23

Completion

2017-08-23

Countries

• United States

Study Locations