Vascular Complications
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate | 1 year | Number of patent common femoral arteries at one year |
| Reintervention rate | 1 year | Number of reinterventions on the treated vessels |
| Amputation rate | 1 year | Number of amputations at the side of the treated common femoral artery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hungary