ProjectCeraFlex PMCF – CeraFlexTM PFO Closure System Post-Market Clinical Follow-up Study
Basic data
Acronym:
CeraFlex PMCF
Title:
CeraFlexTM PFO Closure System Post-Market Clinical Follow-up Study
Duration:
16/07/2024 to 31/12/2028
Abstract / short description:
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.
Involved staff
Managers
Faculty of Medicine
University of Tübingen
University of Tübingen
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Other staff
Faculty of Medicine
University of Tübingen
University of Tübingen
Local organizational units
Internal Medicine Department III
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Funders
Shenzhen, Guangdong, China