Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window

Summary

TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

Conditions

• Stroke, Acute
• Cerebral Stroke
• Cerebrovascular Stroke
• Apoplexy; Brain

Interventions

DEVICE

Thrombectomy

Mechanical thrombectomy with state of the art thrombectomy devices (i.e. stent-retrievers, aspiration catheters). Devices will be used per instructions for use (IFU).

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.). If applicable, the reason for iv tissue plasminogen activator (tPA) ineligibility has to be documented on the eCRF.

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Eppdata GmbH Hamburg, Germany

  collaborator UNKNOWN

• Aarhus University Hospital

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• Groupe Hospitalier Pitie-Salpetriere

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• University Hospital, Martin

  collaborator OTHER

• Charles University, Czech Republic

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• CHU de Reims

  collaborator OTHER

• Epidemiological and Clinical Research Information Network

  collaborator OTHER

• STROKE ALLIANCE FOR EUROPE

  collaborator UNKNOWN

• International Consortium for Health Outcome Measurement, Inc.

  collaborator OTHER

• Europan Society for Minimally Invasive Neurological Therapy

  collaborator UNKNOWN

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Hospital Heidelberg

  lead OTHER

Principal Investigators

• Götz Thomalla, MD · Coordination and Project Management Tension, Neurology, UKE Hamburg, Germany

• Martin Bendszus, MD · Central Trial Management Tension, Neuroradiology, UHHeidelberg, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-20

Primary Completion

2023-05-31

Completion

2023-11-15

FDA Device

Yes

Countries

• Austria
• Canada
• Czechia
• Denmark
• France
• Germany
• Norway
• Slovakia
• Spain
• Switzerland

Study Locations