Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery

Conditions
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Vascular Complications

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate | Number of patent common femoral arteries at one year | 1 year | 
| Reintervention rate | Number of reinterventions on the treated vessels | 1 year | 
| Amputation rate | Number of amputations at the side of the treated common femoral artery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate | Number of significant (peak systolic velocity ratio > 2,4) restenoses found at one year | 1 year | 
| Walking disturbance rate | Number of any new onset walking impairment | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covered stent, bleeding, closure device, pseudoaneurysm, stenosis, stent fracture