Phase
Condition
Cerebral Ischemia
Stroke
Treatment
Direct to Angio Suite (DTAS) Philips' CBCT triage
Conventional CT/MR triage
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is 18 years of age or older, or of legal age to give informed consent perstate or national law.
Baseline NIHSS score obtained prior to randomization must be equal or higher than 10points.
Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2).
Subjects suspected of acute ischemic stroke with an estimated arrival time at astroke center (clinical investigational site participating in this study) < 6 hoursfrom symptom onset. Symptom onset is defined as point in time the patient was lastknown well (at baseline).
Informed consent obtained from patient or his or her legally designatedrepresentative (if locally required).
Angiography suite immediately available.
Endovascular treatment team immediately available (Neurologist,Neurointerventionist, Anesthesiologist, Nursing, Technicians as per local standardpractice)
Exclusion
Exclusion Criteria:
Clinical exclusion criteria:
Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulanttherapy with INR > 3.0
Known baseline platelet count < 30.000/μL
Baseline blood glucose of < 50mg/dL (< 2.78mmol/l)
For patients receiving thrombolysis: severe, sustained hypertension (SBP > 185 mm Hgor DBP > 110 mm Hg). Note: If the blood pressure can be successfully reduced andmaintained at the acceptable level using AHA/ASA guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled.
Patients from a transfer center (Primary Stroke Center) with a CT/MR that is notrequired to be redone in the Comprehensive Stroke Center as per discretion of thephysician or per local standards (e.g. CT/MR less then 90 minutes old).
Patients in coma (NIHSS item of consciousness >1) defined as totally unresponsive;responding only with reflexes or being areflexic (Intubated patients for transfercould be randomized only in case an NIHSS is obtained by a neurologist priortransportation).
Patients with extreme vomiting
Patients that are extremely agitated
Seizures at stroke onset which would preclude obtaining a baseline NIHSS
Serious, advanced, or terminal illness with anticipated life expectancy of less thanone year.
Patients acquired stroke while in-hospital
History of life threatening allergy (more than rash) to contrast medium
Cerebral vasculitis
Patients with a pre-existing neurological or psychiatric disease that would confoundthe neurological or functional evaluations, mRS score at baseline must be ≤2. Thisexcludes patients who are severely demented, require constant assistance in anursing home type setting or who live at home but are not fully independent inactivities of daily living (toileting, dressing, eating, cooking and preparingmeals, etc.)
Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitorfrom overseas).
Patients with unstable clinical status who require emergent life support care
Any condition that, in the judgment of the investigator could impose hazards to thepatient if study therapy is initiated or affect the participation of the patient inthe study.
Subject participates in a potentially confounding drug or device trial during thecourse of the study.
Woman of childbearing potential who is known to be pregnant on admission.
Subject meets an exclusion criteria according to national law (e.g. age, pregnantwoman, breast feeding woman)
Subject is Philips employee or their family members residing with this Philipsemployee.
Study Design
Study Description
Connect with a study center
La Sagrada Familia Clinic
José Hernández,
ArgentinaSite Not Available
La Sagrada Familia Clinic
José Hernández 3433325,
ArgentinaActive - Recruiting
Hospital Geral de Fortaleza
Fortaleza,
BrazilSite Not Available
Hospital Geral de Fortaleza
Fortaleza 3399415,
BrazilActive - Recruiting
Hospital de Base
São José do Rio Preto 3448639,
BrazilSite Not Available
Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Vitória,
BrazilSite Not Available
Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Vitória 3444924,
BrazilActive - Recruiting
Hospices Civils de Lyon
Lyon,
FranceSite Not Available
Hospices Civils de Lyon
Lyon 2996944,
FranceCompleted
CHU Montpellier
Montpellier,
FranceSite Not Available
CHU Montpellier
Montpellier 2992166,
FranceSite Not Available
Bicêtre Hospital
Paris,
FranceSite Not Available
Bicêtre Hospital
Paris 2988507,
FranceActive - Recruiting
University Hospital Bonn (UKB Universitätsklinikum Bonn)
Bonn, 53127
GermanySite Not Available
University Hospital Bonn (UKB Universitätsklinikum Bonn)
Bonn 2946447, 53127
GermanyActive - Recruiting
Klinikum Kassel
Kassel,
GermanySite Not Available
Klinikum Kassel
Kassel 2892518,
GermanyActive - Recruiting
Universitätsklinikum Schleswig-Holstein Lübeck
Lübeck, 23562
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein Lübeck
Lübeck 2875601, 23562
GermanyActive - Recruiting
Klinikum rechts der Isar der TU München
Munich,
GermanySite Not Available
Klinikum rechts der Isar der TU München
Munich 2867714,
GermanyActive - Recruiting
Haaglanden Medical Center
Den Haag,
NetherlandsSite Not Available
St. Antonius Ziekenhuis
Nieuwegein,
NetherlandsSite Not Available
St. Antonius Ziekenhuis
Nieuwegein 2750325,
NetherlandsCompleted
Haaglanden Medical Center
The Hague 2747373,
NetherlandsSite Not Available
University Emergency Hospital Bucharest
Bucharest,
RomaniaSite Not Available
University Emergency Hospital Bucharest
Bucharest 683506,
RomaniaSite Not Available
Hospital Clinico San Carlos
Madrid, Moncloa - Aravaca 28040
SpainSite Not Available
Hospital Clinico San Carlos
Madrid 3117735, Moncloa - Aravaca 28040
SpainActive - Recruiting
Hospital Universitari de Bellvitge
Barcelona,
SpainSite Not Available
Vall d'Hebron University Hospital
Barcelona,
SpainSite Not Available
Vall d'Hebron University Hospital
Barcelona 3128760,
SpainActive - Recruiting
Hospital Universitari Doctor Josep Trueta de Girona
Girona,
SpainSite Not Available
Hospital Universitari Doctor Josep Trueta de Girona
Girona 3121456,
SpainSite Not Available
Hospital Virgen del Rocio
Sevilla,
SpainSite Not Available
Hospital Virgen del Rocio
Seville 2510911,
SpainActive - Recruiting
İstanbul Aydin University medical park florya hospital
Istanbul,
TurkeySite Not Available
İstanbul Aydin University medical park florya hospital
Istanbul 745044,
Turkey (Türkiye)Completed
Baptist Medical Center
Jacksonville, Florida 32207
United StatesSite Not Available
Baptist Medical Center
Jacksonville 4160021, Florida 4155751 32207
United StatesActive - Recruiting
Grady Memorial Hospital/Emory University
Atlanta, Georgia 30303
United StatesSite Not Available
Grady Memorial Hospital/Emory University
Atlanta 4180439, Georgia 4197000 30303
United StatesSite Not Available
University of Massachusetts
Worcester, Massachusetts 01605
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
Montefiore Medical Center
The Bronx, New York 10467
United StatesSite Not Available
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available

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