Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
NCT04437303
Aortic Valve Disease, Aortic Valve Stenosis
Aalst, Belgium
View Trial DetailsNCT Number: NCT05220540
The aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access.
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Notify Me18 year and older
All sexes
Observational
University of Szeged, Albert Szent-Györgyi Health Center, Second Department of Medicine and Cardiology Centre, Szeged, Csongrád-Csanád, Hungary
In the past decades, there has been a paradigm shift in the field of vascular surgery, with endovascular interventions replacing traditional open surgical procedures on an increasing scale. Most of these interventions are performed via the femoral artery. Even with modern percutaneous vascular closure devices, interventional laboratories report a high incidence of vascular complications, most commonly bleeding. Interventional procedures are gaining ground as an alternative to surgery. Having regard to the fact that femoral arteries are in constant motion due to their location and are subject to intense bending forces, the long-term durability of stents has been questioned in the absence of long-term follow-up data. There is currently no broad consensus on the strategy of care for vascular complications, and overall the decision is left to the discretion of the interventionalist, largely determined by the available local resources and infrastructure. The use of covered stents is an option for endovascular treatment of the complications: the self expanding nitinol framed stent graft with polytetrafluoroethylene (PTFE) coating and the cobalt-chrome framed, also PTFE coated balloon expandable stent. The main aim of this research is to analyse the short- and long-term outcome of these alternatives.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Number of patent common femoral arteries at one year
Time frame: 1 year
Number of reinterventions on the treated vessels
Time frame: 1 year
Number of amputations at the side of the treated common femoral artery
Time frame: 1 year
Number of significant (peak systolic velocity ratio > 2,4) restenoses found at one year
Time frame: 1 year
Number of any new onset walking impairment
Semmelweis University Heart and Vascular Center
Other
Acronym: BEST-CFA
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