Clinical trial NCT05220540: Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery
Official title: Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Complications
Keywords: covered stent
bleeding
closure device
pseudoaneurysm
stenosis
stent fracture
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing either transcathether aortic valve repair (TAVR), endovascular aortic repair (EVAR) or thoracic endovascular aortic repair (TEVAR) via percutaneous femoral access resulting in access site complication, or patients who undergo endovascular therapy of common femoral artery disease, managed by balloon-expandable covered stent(s).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* intervention from the left or right common femoral artery
* access complication treated by balloon expandable covered stent(s) or common femoral artery disease treated by balloon-expandable covered stent(s)

Exclusion criteria:

* none

Primary outcomes:
measure: Primary patency rate
timeFrame: 1 year
measure: Reintervention rate
timeFrame: 1 year
measure: Amputation rate
timeFrame: 1 year
Secondary outcomes:
measure: Restenosis rate
timeFrame: 1 year
measure: Walking disturbance rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged, Albert Szent-Györgyi Health Center, Second Department of Medicine and Cardiology Centre
state: Csongrád-Csanád
city: Budapest
country: Hungary
facility: Gottsegen National Cardiovascular Center
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
Study officials:
affiliation: Semmelweis University Heart and Vascular Center
name: Csaba Csobay-Novák, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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