Thrombectomy in Patients Ineligible for iv tPA

Summary

the purpose of this study is to to compare the safety and effectiveness of stent-retrievers as a device class group with best medical care alone in the treatment of acute ischemic stroke (AIS) in patients who are not eligible for IV-tPA up to 8 hours of symptom onset.

Conditions

• Ischemic Stroke

Interventions

DEVICE

Thrombectomy

Stent retriever are intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease by providing temporary bypass across the occlusion and/or by the non-surgical removal of emboli and thrombi. They may be used with aspiration and with the injection or infusion of contrast media and/or other fluids. For subjects enrolled in this protocol who are randomly assigned to undergo the thrombectomy procedure, the device will be used according to the Instructions-for-Use (IFU) that is packaged with the device.

OTHER

Best medical care

Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.).

Sponsors & Collaborators

• University Hospital, Aachen

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• Vivantes Krankenhaus Berlin Neukölln

  collaborator UNKNOWN

• Ruhr University of Bochum

  collaborator OTHER

• Klinikum Dortmund Wirbelsäulenchirurgie

  collaborator OTHER

• University of Erlangen-Nürnberg Medical School

  collaborator OTHER

• Alfried Krupp Krankenhaus

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• University Medical Center Goettingen

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Universitätsklinik für Neurologie, Innsbruck

  collaborator OTHER

• Universitätsklinikum Köln

  collaborator OTHER

• The Wagner-Jauregg Provincial Neuropsychiatric Clinic

  collaborator INDIV

• LMU Klinikum

  collaborator OTHER

• Klinikum rechst der Isar Technische Universitaet Muenchen

  collaborator UNKNOWN

• KLINIKUM VEST Recklinghausen

  collaborator UNKNOWN

• Wuerzburg University Hospital

  collaborator OTHER

• Asklepios Kliniken Hamburg GmbH

  collaborator OTHER

• University Hospital Heidelberg

  lead OTHER

Principal Investigators

• Martin Bendszus, MD · University Hospital Heidelberg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2017-02-01

Completion

2017-02-01

Countries

• Austria
• Germany

Study Locations