the purpose of this study is to to compare the safety and effectiveness of stent-retrievers as a device class group with best medical care alone in the treatment of acute ischemic stroke (AIS) in patients who are not eligible for IV-tPA up to 8 hours of symptom onset.
This is a prospective, binational (Germany and Austria), two-arm, randomized, controlled, open label, blinded endpoint post-market study to compare the safety and effectiveness of stent retrievers for thrombectomy compared to best medical treatment alone in acute ischemic stroke (AIS) patients not eligible for IV-tPA treatment.
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").
Trial Stopped: Recruitment is on hold until MR CLEAN, ESCAPE, EXTEND-IA, and SWIFt PRIME have been evaluated.
- Thrombectomy Device
Intervention Desc: 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. ARM 1: Kind: Experimental Label: Thrombectomy Description: 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).
- Best medical care Other
Other Names: Control group Intervention Desc: 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.). ARM 1: Kind: Experimental Label: Best medical care Description: Best clinical care in dedicated stroke unit
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||mRS Shift||90 (+/-14) days after treatment||No|
|Secondary||Neurological outcome||90 (+/- 14) days after treatment||No|
|Secondary||Health Status||90 (+/-14) days after treatment||No|
|Secondary||Infarct volume||30 (-/+ 6) hours after treatment||No|
|Secondary||Successful Recanalization||30 (-/+ 6) hours after treatment||No|
- University Hospital Heidelberg Lead
- Klinikum Dortmund gGmbH
- Vivantes Krankenhaus Berlin Neukölln
- Landes-Nervenklinik Wagner-Jauregg, Linz
- Wuerzburg University Hospital
- Universitätsklinikum Würzburg
- University Hospital Freiburg
- Klinikum rechst der Isar Technische Universitaet Muenchen
- University of Erlangen-Nürnberg Medical School
- Nervenklinik Linz
- Universitätsklinikum Hamburg-Eppendorf
- Universitätsklinikum Schleswig-Holstein (Kiel)
- UniversitätsKlinikum Heidelberg
- Alfried Krupp Krankenhaus Essen
- Knappschaftskrankenhaus Ruhr University of Bochum
- University Hospital, Aachen
- Klinikum Augsburg
- KLINIKUM VEST Recklinghausen
- Asklepios Kliniken Hamburg GmbH
- Klinikum der Universitaet Muenchen
- University Hospital, Essen
- Universitätsklinikum Köln
- Universitätsklinik für Neuroradiologie Innsbruck
- University Medical Center Goettingen