EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke

PHASE3CompletedINTERVENTIONAL
Enrollment

221

Participants

Timeline

Start Date

February 8, 2017

Primary Completion Date

June 30, 2019

Study Completion Date

June 30, 2019

Conditions
StrokeIschemic Stroke
Interventions
PROCEDURE

Thrombectomy

Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever Solitaire FR® and/or thromboaspiration with Penumbra System® versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.

DEVICE

Stentriever Solitaire FR® or Penumbra System®

Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.

Trial Locations (15)

90035903

Hospital de Clínicas de Porto Alegre, Porto Alegre

Unknown

Hospital Geral de Fortaleza/SUS, Fortaleza

Hospital Estadual Central, Vitória

Hospital Geral Roberto Santos, Salvador

Hospital de Base do Distrito Federal, Brasília

Hospital de Clínicas da Universidade Federal do Paraná, Curitiba

Hospital São José do Avaí, Itaperuna

UNIÃO BRASILEIRA DE EDUCAÇÃO E ASSISTENCIA, Hospital São Lucas PUCRS, Porto Alegre

Hospital Governador Celso Ramos, Florianópolis

Clinica Neurologica e Neurocirurgica de Joinville S/S Ltda, Joinville

Hospital das Clínicas da Faculdade de Medicina de Botucatu, Botucatu

Hospital de Clínicas - UNICAMP, Campinas

Hospital de Clínicas de Ribeirão Preto, Ribeirão Preto

Irmandade da Santa Casa de Misericórdia, São Paulo

Universidade Federal de São Paulo - UNIFESP/EPM, São Paulo

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Ministry of Health, Brazil

OTHER_GOV

collaborator

Medtronic

INDUSTRY

collaborator

Penumbra Inc.

INDUSTRY

collaborator

iSchemaView, Inc

UNKNOWN

collaborator

Brainomix Limited

INDUSTRY

lead

Hospital de Clinicas de Porto Alegre

OTHER