Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter.
Prospective, interventional treatment, single-arm, open-label, multi-center trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Self-expandable Credo® stent together with NeuroSpeed® PTA balloon catheter. Credo® and NeuroSpeed® are already CE approved products, for which within ACUTE an additional new indication shall be examined.
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Co-Primary Technical Efficacy Endpoint
Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting).
Time frame: Assessed after interventional procedure
Co-Primary Clinical Efficacy Endpoint
Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2).
Time frame: 90 +/- 10 days after stroke
Primary Safety Endpoints
* Symptomatic intracranial hemorrhage (SICH) as defined in SITS-MOST (within 18-36 hours of treatment) * Device-related procedural complications: Dissection, perforation or rupture of the target vessel, embolism, stent thrombosis or occlusion, stent migration.
Time frame: Within 18-36 hours after treatment
Secondary Efficacy Endpoints
* Categorical shift in MRS 90 (±10) days after stroke * Functional health status and quality of life 90 (±10) days after stroke (EQ-5D) * Infarct growth by 18-36 hours after stroke as compared to predicted infarct growth * Frequency of residual stenosis \> 50 %
Time frame: 90 +/- 10 days after stroke
Secondary Safety Endpoints
* Ischemic stroke in downstream territory of the occluded vessel within 90 (±10) days after stroke * Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours * Embolization in new territories * Mortality 90 (±10) days after stroke * Death or dependency 90 (±10) days after stroke (MRS 4-6)
Time frame: 90 +/- 10 days after stroke
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Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes
Homburg, Germany
Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Mönchengladbach, Germany
Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
Oldenburg, Germany
Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik
Osnabrück, Germany
Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik
Solingen, Germany