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Clinical Trials/NCT05220540
NCT05220540
Completed
Not Applicable

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

Semmelweis University Heart and Vascular Center3 sites in 1 country24 target enrollmentJanuary 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Complications
Sponsor
Semmelweis University Heart and Vascular Center
Enrollment
24
Locations
3
Primary Endpoint
Reintervention rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2010
End Date
August 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Semmelweis University Heart and Vascular Center
Responsible Party
Principal Investigator
Principal Investigator

Csaba Csobay-Novák MD PhD

Head of Noninvasive Imaging

Semmelweis University Heart and Vascular Center

Eligibility Criteria

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:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Reintervention rate

Time Frame: 1 year

Number of reinterventions on the treated vessels

Primary patency rate

Time Frame: 1 year

Number of patent common femoral arteries at one year

Amputation rate

Time Frame: 1 year

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

Secondary Outcomes

  • Restenosis rate(1 year)
  • Walking disturbance rate(1 year)

Study Sites (3)

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