Phase
Condition
Stroke
Cerebral Ischemia
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,
ArgentinaActive - Recruiting
Hospital Geral de Fortaleza
Fortaleza,
BrazilActive - Recruiting
Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Vitória,
BrazilActive - Recruiting
Hospices Civils de Lyon
Lyon,
FranceCompleted
CHU Montpellier
Montpellier,
FranceSite Not Available
Bicêtre Hospital
Paris,
FranceActive - Recruiting
University Hospital Bonn (UKB Universitätsklinikum Bonn)
Bonn, 53127
GermanyActive - Recruiting
Klinikum Kassel
Kassel,
GermanyActive - Recruiting
Universitätsklinikum Schleswig-Holstein Lübeck
Lübeck, 23562
GermanyActive - Recruiting
Klinikum rechts der Isar der TU München
Munich,
GermanyActive - Recruiting
Haaglanden Medical Center
Den Haag,
NetherlandsSite Not Available
St. Antonius Ziekenhuis
Nieuwegein,
NetherlandsCompleted
University Emergency Hospital Bucharest
Bucharest,
RomaniaSite Not Available
Hospital Clinico San Carlos
Madrid, Moncloa - Aravaca 28040
SpainActive - Recruiting
Hospital Universitari de Bellvitge
Barcelona,
SpainSite Not Available
Vall d'Hebron University Hospital
Barcelona,
SpainActive - Recruiting
Hospital Universitari Doctor Josep Trueta de Girona
Girona,
SpainSite Not Available
Hospital Virgen del Rocio
Sevilla,
SpainActive - Recruiting
İstanbul Aydin University medical park florya hospital
Istanbul,
TurkeyCompleted
Baptist Medical Center
Jacksonville, Florida 32207
United StatesActive - Recruiting
Grady Memorial Hospital/Emory University
Atlanta, Georgia 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
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