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

Completed

• Conditions: Vascular Complications

• Registration Number: NCT05220540
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

Study Timeline

• Study Start: 2010-01-01
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-02
• Status Verified: 2023-02
• Primary Completion: 2023-08-10
• Study Completion: 2023-08-31
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reintervention rate	1 year	Number of reinterventions on the treated vessels
Primary patency rate	1 year	Number of patent common femoral arteries at one year
Amputation rate	1 year	Number of amputations at the side of the treated common femoral artery

Secondary Outcome Measures

Name	Time	Method
Restenosis rate	1 year	Number of significant (peak systolic velocity ratio \> 2,4) restenoses found at one year
Walking disturbance rate	1 year	Number of any new onset walking impairment

Trial Locations

Locations (3)

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

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

Gottsegen National Cardiovascular Center; 🇭🇺 Budapest, Hungary