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Goal of the study 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® heal Stent.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter | Device | Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure. | • Technical success defined as successful recanalization of the occluded vessel (expanded treatment in cerebral ischemia score (eTICI) of 2b-3) at the end of the procedure. | Assessed at the end of the treatment procedure. |
| Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure. | • Good clinical outcome 90 (± 20) days after stroke defined as a score of 0-2 on the modified Ranking Scale (mRS 0-2). | 90 (± 20) days. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were treated with CREDO® heal due to acute ischemic stroke and proven occlusion with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery, which is suitable to PTA and stenting based on the decision of the treating physician.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau | Recruiting | Aschaffenburg | 63739 | Germany |
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| Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg | Recruiting | Augsburg | 86156 | Germany |
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| Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn | Recruiting | Bonn | Germany |
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| Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide | Recruiting | Bremerhaven | Germany |
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| Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden | Recruiting | Dresden | 01307 | Germany |
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| Klinik für Radiologie und Neuroradiologie, Sana Klinikum | Recruiting | Duisburg | Germany |
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| Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt | Recruiting | Erfurt | 99089 | Germany |
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| Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle | Recruiting | Halle | 06120 | Germany |
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| Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona | Recruiting | Hamburg | Germany |
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| Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
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| Radiologie / Neuroradiologie, Askleopis Klinik St. Georg | Recruiting | Hamburg | Germany |
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| Klinik für Neuroradiologie, Westpfalz-Klinikum | Recruiting | Kaiserslautern | Germany |
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| Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken | Recruiting | Lübeck | Germany |
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| Interventionelle Neuroradiologie, Universitätsklinikum Münster | Recruiting | Münster | Germany |
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| Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg | Recruiting | Oldenburg | 26122 | Germany |
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| Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest | Recruiting | Recklinghausen | Germany |
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| Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum | Recruiting | Solingen | 42653 | Germany |
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