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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05220540
Acronym
BEST-CFA
Enrollment
24
Registered
2022-02-02
Start date
2010-01-01
Completion date
2023-08-31
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Complications

Keywords

covered stent, bleeding, closure device, pseudoaneurysm, stenosis, stent fracture

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.

Interventions

None listed

Sponsors

Semmelweis University Heart and Vascular Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary patency rate1 yearNumber of patent common femoral arteries at one year
Reintervention rate1 yearNumber of reinterventions on the treated vessels
Amputation rate1 yearNumber of amputations at the side of the treated common femoral artery

Secondary

MeasureTime frameDescription
Restenosis rate1 yearNumber of significant (peak systolic velocity ratio \> 2,4) restenoses found at one year
Walking disturbance rate1 yearNumber of any new onset walking impairment

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026