Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery (BEST-CFA)

November 20, 2023 updated by: Csaba Csobay-Novák MD PhD, Semmelweis University Heart and Vascular Center
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis University Heart and Vascular Center
      • Budapest, Hungary, 1096
        • Gottsegen National Cardiovascular Center
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, 6725
        • University of Szeged, Albert Szent-Györgyi Health Center, Second Department of Medicine and Cardiology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency rate
Time Frame: 1 year
Number of patent common femoral arteries at one year
1 year
Reintervention rate
Time Frame: 1 year
Number of reinterventions on the treated vessels
1 year
Amputation rate
Time Frame: 1 year
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
Time Frame: 1 year
Number of significant (peak systolic velocity ratio > 2,4) restenoses found at one year
1 year
Walking disturbance rate
Time Frame: 1 year
Number of any new onset walking impairment
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Investigators

  • Principal Investigator: Csaba Csobay-Novák, MD, PhD, Semmelweis University Heart and Vascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

August 10, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AFC2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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