ProjektCeraFlex PMCF – CeraFlexTM PFO Closure System Post-Market Clinical Follow-up Study
Grunddaten
Akronym:
CeraFlex PMCF
Titel:
CeraFlexTM PFO Closure System Post-Market Clinical Follow-up Study
Laufzeit:
16.07.2024 bis 31.12.2028
Abstract / Kurz- beschreibung:
The purpose is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.
1. Indication(s) for PFO Occluder closure in the CeraFlex™ PFO Occluder IFU:
Confirmed PFO by medical examination; Associated with TIA or cryptogenic stroke.
2. Device Size Selection in the CeraFlex™ PFO Occluder IFU: Measure the distance from the defect to the aorta root. Measure the distance from the defect to the SVC rim. Select a device with radius of right disc will not exceed the lesser of these two distances.
Primary Endpoint:
Procedural success rate = Procedure success is defined as a composite of:
1) absence of peri-procedural stroke related events (ischemic stroke, cryptogenic stroke, or TIA), device embolization, cardiac or vascular perforation or death, at discharge or 7 days post procedure, whichever comes first;
2) successful implantation of the device at procedure.
1. Indication(s) for PFO Occluder closure in the CeraFlex™ PFO Occluder IFU:
Confirmed PFO by medical examination; Associated with TIA or cryptogenic stroke.
2. Device Size Selection in the CeraFlex™ PFO Occluder IFU: Measure the distance from the defect to the aorta root. Measure the distance from the defect to the SVC rim. Select a device with radius of right disc will not exceed the lesser of these two distances.
Primary Endpoint:
Procedural success rate = Procedure success is defined as a composite of:
1) absence of peri-procedural stroke related events (ischemic stroke, cryptogenic stroke, or TIA), device embolization, cardiac or vascular perforation or death, at discharge or 7 days post procedure, whichever comes first;
2) successful implantation of the device at procedure.
Beteiligte Mitarbeiter/innen
Leiter/innen
Medizinische Fakultät
Universität Tübingen
Universität Tübingen
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Weitere Mitarbeiter/innen
Medizinische Fakultät
Universität Tübingen
Universität Tübingen
Lokale Einrichtungen
Abteilung Innere Medizin III
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Geldgeber
Shenzhen, Guangdong, China