Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window

NACompletedINTERVENTIONAL
Enrollment

1,078

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

June 30, 2018

Study Completion Date

June 30, 2018

Conditions
Ischemic Stroke
Interventions
DEVICE

Active Sphenopalatine Ganglion (SPG) Stimulation

SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.

DEVICE

Sham Sphenopalatine Ganglion (SPG) Stimulation

Sham SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.

Trial Locations (73)

27401

Guilford Neurologic Associates, Greensboro

29203

Palmetto Health Richland, Columbia

34239

Intercoastal Medical Group, Sarasota

37403

Erlanger Stroke Center, Chattanooga

43606

University of Toledo Medical Center- Campus 1, Toledo

University of Toledo Medical Center- Campus 2, Toledo

60190

Central DuPage Hospital, Winfield

Unknown

Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences, Calgary

Department of Medicine, Stroke Program, University of Alberta Hospital, Edmonton

University Hospital of Ostrava, Ostrava Poruba, Poruba

General University Hospital, Prague

Vitkovicka nemocnice a.s. Ostrava Vitkovice, Vítkovice

Aarhus University Hospital, Aarhus

Helsinki University Hospital, Helsinki

Kuopio University Hospital, Kuopio

Hospital de la Cavale Blanche, Brest

Hospital Nord Laennec, Nantes

Hospital Saint Roch, Nice

Hopital Lariboisiere, Paris

Hospital Pontchaillou, Rennes

Unimed Adjara Batumi Referral Hospital, Batumi

Kutaisi Referral Hospital, Kutaisi

Rustavi Central Hospital, Rustavi

Emergency Neurology Clinic Neurology Ltd., Tbilisi

First University Clinic, Tbilisi

High Technology Medical Center University Clinic LTD., Tbilisi

Zugdidi Referral Hospital, Zugdidi

Altenburg Clinic of Neurology, Altenburg

Bad Neustadt Neurological Clinic, Bad Neustadt an der Saale

Center for Stroke Research at Charite University of Berlin, Berlin

Erlangen University Clinic, Erlangen

Essen University Clinic, Essen

Heidelberg University Clinic, Heidelberg

Leipzig University Clinic, Leipzig

Technical University Munich, Munich

Schwarzwald-Baar Clinic, Villingen-Schwenningen

Prince of Wales Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

Barzilai Medical Center, Ashkelon

Hadassah Medical Center, Jerusalem

Rabin Medical Center, Petah Tikva

Sourasky Medical Center, Tel Aviv

The Chaim Sheba Medical Center, Tel Litwinsky

Hospital Sant'Andrea delle Fratte, Perugia

Policlinico Umberto I, Roma

University Clinic for Neurology, Skopje

Bialystok University Hospital, Bialystok

Konske Hospital, Gmina Końskie

University Hospital in Krakow, Krakow

Sandomierz Hospital, Sandomierz

Torun Hospital, Torun

Institute of Psychiatry and Neurology, Warsaw

Hospital Fernando Fonseca, Amadora

Hospital de Santo Antonio, Porto

Unidade de AVC Centro Hospitalar São João, Porto

Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião, Santa Maria

Special Hospital for Cerebrovascular Disease Sveti Sava, Belgrade

Clinical Centre of Vojvodina, Novi Sad

Clinical Hospital Center Zemun, Zemun

Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská, Nová Ves

Neurologické Oddelenie FN Trnava, Fakultná Nemocnica, Trnava

Hospitalario Universitario de Albacete, Albacete

Hospital de la Santa Creu I Sant Pau, Barcelona

Hospital del Mar, Barcelona

Hospital Universitari de Bellvitge, Barcelona

Hospital Vall d'Hebron, Barcelona

Hospital Arnau de Vilanova, Lleida

Hospital Gregorio Maranon, Madrid

Ramon Y Cajal, Madrid

Hospital Universitario Son Dureta, Palma de Mallorca

Complejo Hospitalarion Univiersitario de Santiago, Santiago de Compostela

Valladolid - Hospital Clinico, Valladolid

Lviv National Medical University, Lviv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BrainsGate

INDUSTRY