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Completed

NCT Number: NCT05220540

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Szeged, Albert Szent-Györgyi Health Center, Second Department of Medicine and Cardiology Centre, Szeged, Csongrád-Csanád, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary patency rate

    Time frame: 1 year

    Number of patent common femoral arteries at one year

  2. Reintervention rate

    Time frame: 1 year

    Number of reinterventions on the treated vessels

  3. Amputation rate

    Time frame: 1 year

    Number of amputations at the side of the treated common femoral artery

Secondary outcomes

  1. Restenosis rate

    Time frame: 1 year

    Number of significant (peak systolic velocity ratio > 2,4) restenoses found at one year

  2. Walking disturbance rate

    Time frame: 1 year

    Number of any new onset walking impairment

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Registry information

Acronym: BEST-CFA

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2022
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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