Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2014-03-31
2017-02-01
Brief Summary
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Detailed Description
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Patients who meet the inclusion criteria will be randomized to one of the following two treatment arms:
* best medical care alone or
* best medical care plus endovascular thrombectomy with stent retriever (referred to as thrombectomy).
Endpoints in this prospective open label study will be assessed blinded to the treatment assignment of the patient (PROBE design). This study will be conducted in up to 20 centers in Germany and Austria. This is an adaptive design study, in which there are prospectively stated interim analyses with specified stopping rules, which allow for the possibility of the study to terminate early based on either a determination of study success or of the futility to continue further enrollment.
Up to six hundred (600) subjects, 300 per treatment group, will be enrolled and randomized in the study for the Intent to Treat (ITT) analysis set. The randomization will be stratified by time from symptom onset and stroke severity (NIHSS). The expected duration of each subject"s enrollment is approximately 90 days. Subjects will be followed with assessments at 30 (+/-6) hours, hospital discharge, and 90 (+/-14) days post stroke.
A blinded core laboratory will assess baseline imaging to confirm vessel occlusion and determine ASPECT score, 30 (+/- 6) hours post treatment imaging to assess presence of ICH, and to measure core infarct volume.
The primary effectiveness endpoint for a subject is the blinded evaluation of the ordinal mRS outcome at 90 days post-stroke. The primary effectiveness endpoint analysis is a chi-square test of the difference in linear trends in mRS outcomes at 90 days post-stroke between treatment groups ("mRS shift analysis").
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Best medical care
Best clinical care in dedicated stroke unit
Best medical care
Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.).
Thrombectomy
All subjects randomly assigned to the thrombectomy arm, except those with rapidly improving neurologic symptoms or no angiographic evidence of occlusion, will be treated with the endorsed study devices (stent retriever).
Thrombectomy
Stent retriever are intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease by providing temporary bypass across the occlusion and/or by the non-surgical removal of emboli and thrombi. They may be used with aspiration and with the injection or infusion of contrast media and/or other fluids. For subjects enrolled in this protocol who are randomly assigned to undergo the thrombectomy procedure, the device will be used according to the Instructions-for-Use (IFU) that is packaged with the device.
Interventions
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Thrombectomy
Stent retriever are intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease by providing temporary bypass across the occlusion and/or by the non-surgical removal of emboli and thrombi. They may be used with aspiration and with the injection or infusion of contrast media and/or other fluids. For subjects enrolled in this protocol who are randomly assigned to undergo the thrombectomy procedure, the device will be used according to the Instructions-for-Use (IFU) that is packaged with the device.
Best medical care
Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).
* Randomization within 7 hours after stroke onset.
* Endovascular treatment is expected to be finished within 8 hours after symptom onset by judgment of the interventional Neuroradiologist in charge.
* Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.
* Female and male patient between 18-80 years of age
* NIHSS Score of \>7 and \<25
* Patient signed informed consent (IC) form by patient, legal representative, or by an independent physician who is familiar with this types of illness if the other options are not possible.
* A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA).
* Prior to new focal neurological deficit, mRS score was ≤1.
Exclusion Criteria
* Patient with an international normalized ratio (INR) of \>3
* Patient is an active participant in another drug or device treatment trial for any disease state, or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
* Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
* Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
* Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
* Patient has history of contraindication for contrast medium.
* Patient is known to have infective endocarditis
* CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on unenhanced CT and cerebral blood volume (CBV) drop on CBV maps on Computed Tomography Perfusion (CTP), or, alternatively as per institutional standard, restricted diffusion on Diffusion weighted imaging (DWI) with an Alberta Stroke Program Early CT score (ASPECTs) of 6 or less
* Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.
* Patient"s anticipated life expectancy is less than 6 Months.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Aachen
OTHER
University Hospital Augsburg
OTHER
Vivantes Krankenhaus Berlin Neukölln
UNKNOWN
Ruhr University of Bochum
OTHER
Klinikum Dortmund Wirbelsäulenchirurgie
OTHER
University of Erlangen-Nürnberg Medical School
OTHER
Alfried Krupp Krankenhaus
OTHER
University Hospital, Essen
OTHER
University Hospital Freiburg
OTHER
University Medical Center Goettingen
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Universitätsklinik für Neurologie, Innsbruck
OTHER
Universitätsklinikum Köln
OTHER
The Wagner-Jauregg Provincial Neuropsychiatric Clinic
INDIV
LMU Klinikum
OTHER
Klinikum rechst der Isar Technische Universitaet Muenchen
UNKNOWN
KLINIKUM VEST Recklinghausen
UNKNOWN
Wuerzburg University Hospital
OTHER
Asklepios Kliniken Hamburg GmbH
OTHER
University Hospital Heidelberg
OTHER
Responsible Party
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Susanne Bonekamp
Prof. Dr. Martin Bendszus
Principal Investigators
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Martin Bendszus, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg
Locations
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Institut für Radiologie Oö. Gesundheits- und Spitals-AG Landes-Nervenklinik Wagner-Jauregg
Linz, , Austria
Klinik für Diagnostische und Interventionelle Neuroradiologie Universitätsklinikum Aachen
Aachen, , Germany
Klinische und interventionelle Neuroradiologie Vivantes Klinikum Neukölln
Berlin, , Germany
Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, , Germany
University Clinic Bochum
Bochum, , Germany
Diagnostik , Neuroradiologie, Universitätsklinikum Köln
Cologne, , Germany
Kinik für Radiologie und Neuroradiologie
Dortmund, , Germany
Abteilung für Neuroradiologie Universitätsklinikum Erlangen
Erlangen, , Germany
Klinik für Radiologie und Neuroradiologie Alfried Krupp Krankenhaus
Essen, , Germany
Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie Universitätsklinikum Essen
Essen, , Germany
Klinik für Neuroradiologie Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Institut für Diagnostische & Interventionelle Neuroradiologie Universitätsmedizin Göttingen
Göttingen, , Germany
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention
Hamburg, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Universität Heidelberg, Neuroradiologie
Heidelberg, , Germany
Abteilung für Neuroradiologie Klinikum der Universität München Campus
München, , Germany
Abteilung für Diagnostische & Interventionelle Neuroradiogie Klinikum rechts der Isar der TU München
München, , Germany
Klinik für Radiologie, Neuroradiologie und Nuklearmedizin Behandlungszentrum Knappschaftskrankenhaus Recklinghausen
Recklinghausen, , Germany
Abteilung für Neuroradiologie Universitätsklinikum Würzburg
Würzburg, , Germany
Countries
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References
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Kelly ME, Furlan AJ, Fiorella D. Recanalization of an acute middle cerebral artery occlusion using a self-expanding, reconstrainable, intracranial microstent as a temporary endovascular bypass. Stroke. 2008 Jun;39(6):1770-3. doi: 10.1161/STROKEAHA.107.506212. Epub 2008 Apr 3.
Nogueira RG, Lutsep HL, Gupta R, Jovin TG, Albers GW, Walker GA, Liebeskind DS, Smith WS; TREVO 2 Trialists. Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012 Oct 6;380(9849):1231-40. doi: 10.1016/S0140-6736(12)61299-9. Epub 2012 Aug 26.
Penumbra Pivotal Stroke Trial Investigators. The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke. 2009 Aug;40(8):2761-8. doi: 10.1161/STROKEAHA.108.544957. Epub 2009 Jul 9.
Saver JL, Jahan R, Levy EI, Jovin TG, Baxter B, Nogueira RG, Clark W, Budzik R, Zaidat OO; SWIFT Trialists. Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012 Oct 6;380(9849):1241-9. doi: 10.1016/S0140-6736(12)61384-1. Epub 2012 Aug 26.
Albers GW, Goldstein LB, Hess DC, Wechsler LR, Furie KL, Gorelick PB, Hurn P, Liebeskind DS, Nogueira RG, Saver JL; STAIR VII Consortium. Stroke Treatment Academic Industry Roundtable (STAIR) recommendations for maximizing the use of intravenous thrombolytics and expanding treatment options with intra-arterial and neuroprotective therapies. Stroke. 2011 Sep;42(9):2645-50. doi: 10.1161/STROKEAHA.111.618850. Epub 2011 Aug 18.
Kastner B, Behre S, Lutz N, Burger F, Luntz S, Hinderhofer K, Bendszus M, Hoffmann GF, Ries M. Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses. PLoS One. 2015 Aug 14;10(8):e0135997. doi: 10.1371/journal.pone.0135997. eCollection 2015.
Bendszus M, Thomalla G, Knauth M, Hacke W, Bonekamp S, Fiehler J. Thrombectomy in patients ineligible for iv tPA (THRILL). Int J Stroke. 2015 Aug;10(6):950-5. doi: 10.1111/ijs.12527. Epub 2015 Jun 4.
Other Identifiers
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DRKS00005792
Identifier Type: REGISTRY
Identifier Source: secondary_id
UH-Heidelberg-THRILL
Identifier Type: -
Identifier Source: org_study_id
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