Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke

CompletedOBSERVATIONAL
Enrollment

250

Participants

Timeline

Start Date

October 1, 2017

Primary Completion Date

December 31, 2021

Study Completion Date

March 15, 2022

Conditions
Cerebrovascular StrokeStroke, AcuteCerebral Stroke
Interventions
DEVICE

Sofia

The SOFIA™/ SOFIA™ PLUS Catheter will be used in removal/aspiration of emboli and thrombi following the CE marked Instructions For Use. Enrollment into the study does not change the routine care at the site provided to the patient requiring mechanical thrombectomy treatment.

Trial Locations (15)

4020

Kepler Universitätsklinikum, Linz

5020

Salzburger Landeskliniken, Salzburg

9713

Universitair Medisch Centrum Groningen, Groningen

10117

Charité - Universitätsmedizin Berlin, Berlin

24105

Universitätsklinikum Schleswig-Holstein, Kiel

31059

CHU de Toulouse Hôpital Purpan, Toulouse

33404

Le Centre Hospitalier Universitaire de Bordeaux, Bordeaux

44892

Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum

66421

Universitätsklinikum des Saarlandes, Homburg

69037

Centre Hospitalier Régional Universitaire de Lille, Lille

69120

University Hospital Heidelberg, Heidelberg

86156

Klinikum Augsburg, Augsburg

98158

"Policlinico G. Martino di Messina", Messina

Unknown

Groupe Hospitalier Universitaire Pitié Salpêtrière, Paris

Kremin Bicêtre- Paris Sud University, Paris

All Listed Sponsors
collaborator

Microvention-Terumo, Inc.

INDUSTRY

collaborator

Eppdata Hamburg

UNKNOWN

lead

Dr. Markus Alfred Möhlenbruch

OTHER

NCT03417349 - Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke | Biotech Hunter | Biotech Hunter