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.
Study Type
OBSERVATIONAL
Enrollment
150
a self-expanding stent is used together with a PTA balloon catheter
Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, Germany
RECRUITINGRate of Technical Success
• Technical Success
Time frame: During interventional procedure
Number of Patients with Periprocedural Vascular Events
* Intracranial haemorrhage (symptomatic / asymptomatic) * Death * TIA in the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel * Disabling ischemic stroke (MRS 3-6) in the region of the target vessel * TIA outside the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel * Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel
Time frame: Periprocedural, until 30 days after the interventional procedure
Number of Patients with Cerebrovascular events
* Intracranial haemorrhage (symptomatic / asymptomatic) * Death * TIA in the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel * Disabling ischemic stroke (MRS 3-6) in the region of the target vessel * TIA outside the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel * Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel
Time frame: 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
* Intracranial haemorrhage (symptomatic / asymptomatic) * Death * TIA * Non-disabling ischemic stroke (MRS 0-2) * Disabling ischemic stroke (MRS 3-6) * Interventional re-treatment of the target vessel
Time frame: 30 days after the interventional procedure
Number of Patients with Dissection of the target vessel
Time frame: During interventional procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Uniklinik Köln
Cologne, Germany
RECRUITINGUniversitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie
Düsseldorf, Germany
RECRUITINGAlfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie
Essen, Germany
RECRUITINGInstitut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen
Göttingen, Germany
RECRUITINGUniversitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGAsklepios Klinik Altona, Fachbereich Neuroradiologie
Hamburg, Germany
RECRUITINGUniversitätsklinikum Heidelberg Abteilung für Neuroradiologie
Heidelberg, Germany
RECRUITINGUniversitätsklinikum Homburg
Homburg, Germany
RECRUITINGKlinikum Ingolstadt
Ingolstadt, Germany
RECRUITING...and 6 more locations
Number of Patients with Occlusion of the target vessel
Time frame: 30 days after the interventional procedure
Number of Patients with Myocardial infarction
Time frame: 30 days after the interventional procedure
Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion)
Time frame: 30 days after the interventional procedure