SITS (Safe Implementation of Treatments in Stroke) Open Artery by Thrombectomy in Acute Occlusive Stroke Study

Summary

Ischemic stroke, i.e. irreversible damage of a part of the patient's brain, is caused by the formation of blood clot in the major vessel which gives blood supply to a certain part of the brain. At early time, within the first 4,5 hours, the conventional treatment is to try to dissolve this blood clot with a medication ("thrombolytic drug") which is administered to the blood through the needle in the vein. If the clot still remains there, additional treatment is possible - going directly to the clot via artery and taking it out with a special device. Patients may be included even if they are not treated with intravenous thrombolysis because of contraindication or other reasons. The purpose of the present study is to evaluate the benefit and safety efficacy of thrombectomy and standard stroke care in clinical routine treatment of acute occlusive stroke compared to standard stroke care only.

Conditions

• Ischemic Stroke

Interventions

DEVICE

Stent retriever endovascular device for thrombectomy

Thrombectomy by selected stent retrievers (TREVO, Solitaire, pREset, in special cases all stent retrievers) as additional therapy in major artery occlusion in patients fulfilling criteria for and receiving intravenous thrombolysis

DRUG

Intravenous thrombolysis by alteplase (Actilyse) (optional)

Stroke thrombolysis with Alteplase (Boeringer-Ingelheim, ATC-code B01AD02; a fibrinolytic drug) according to conventional guidelines (0.9 mg/kg, not exceeding 90 mg, given intravenously)

Sponsors & Collaborators

• Swedish Heart Lung Foundation

  collaborator OTHER

• Medtronic - MITG

  collaborator INDUSTRY

• Stryker Nordic

  collaborator INDUSTRY

• Phenox GmbH

  collaborator INDUSTRY

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Nils Wahlgren, Professor · Karolinska Institutet

• Olav Jansen, Professor · University Hospital of Schleswig-Holstein

• Staffan Holmin, M.D., Ph.D. · Karolinska University Hospital, Karolinska Institutet

• Kennedy Lees, M.D., FRCP · University of Glasgow

• Salvatore Mangiafico, M.D., Ph. · Careggi University Hospital

• Lawrence Wong, M.D., Ph.D. · Chinese University of Hong Kong

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2018-01-31

Completion

2018-01-31

Countries

• Sweden

Study Locations