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ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.
ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge.
The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Credo® Stent and NeuroSpeed® PTA balloon catheter | Patients treated with Credo® Stent and NeuroSpeed® PTA balloon catheter in the clinical routine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Credo® Stent, NeuroSpeed® PTA balloon catheter | Device | a self-expanding stent is used together with a PTA balloon catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Technical Success | • Technical Success | During interventional procedure |
| Number of Patients with Periprocedural Vascular Events |
| Periprocedural, until 30 days after the interventional procedure |
| Number of Patients with Cerebrovascular events |
| At hospital discharge - befor the patient leaves the hospital after the intervention; up to 2 weeks, whichever came first |
| Number of Patients with Cerebrovascular Events |
| 30 days after the interventional procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Dissection of the target vessel | During interventional procedure | |
| Number of Patients with Occlusion of the target vessel | 30 days after the interventional procedure | |
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Inclusion Criteria:
- Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)
Exclusion Criteria:
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All patients over 18 with symptomatic intracranial artery stenosis treated with the self-expandable Credo® stent in the participating sites in clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Acandis GmbH | Contact | +49 723 1155 00 | info@acandis.com |
| Name | Affiliation | Role |
|---|---|---|
| Götz Thomalla, MD | Unversity Medical Center Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Knappschaftskrankenhaus Bochum | Recruiting | Bochum | 44892 | Germany |
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| Number of Patients with Myocardial infarction |
| 30 days after the interventional procedure |
| Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion) | 30 days after the interventional procedure |
| Uniklinik Köln | Recruiting | Cologne | 50924 | Germany |
|
| Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie | Recruiting | Düsseldorf | Germany |
|
| Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie | Recruiting | Essen | 45131 | Germany |
|
| Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen | Recruiting | Göttingen | 37075 | Germany |
|
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
|
| Asklepios Klinik Altona, Fachbereich Neuroradiologie | Recruiting | Hamburg | 22769 | Germany |
|
| Universitätsklinikum Heidelberg Abteilung für Neuroradiologie | Recruiting | Heidelberg | 69120 | Germany |
|
| Universitätsklinikum Homburg | Recruiting | Homburg | 66424 | Germany |
|
| Klinikum Ingolstadt | Recruiting | Ingolstadt | 85049 | Germany |
|
| Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie | Recruiting | Magdeburg | 39120 | Germany |
|
| Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie | Recruiting | Mönchengladbach | 41063 | Germany |
|
| Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg | Recruiting | Oldenburg | 26122 | Germany |
|
| Klinikum Osnabrück, Klinik für Neurologie | Recruiting | Osnabrück | 49076 | Germany |
|
| KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie | Recruiting | Recklinghausen | 45657 | Germany |
|
| St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen | Recruiting | Solingen | 42697 | Germany |
|