Stenting of the superficial femoral artery: Submitted to stenting of the superficial femoral artery for stenosis or occlusion causing intermittent claudication or critical limb ischemia
Study summary
Endovascular treatment of superficial femoral artery stenosis/obstruction is still the subject of debate in the scientific literature.
Previous clinical studies have in fact reported conflicting data regarding the benefits of implanting self-expanding Nitinol stents in the superficial femoral artery district compared to simple percutaneous transluminal angioplasty. Invariably, patient comorbidities and anatomic characteristics of the lesions appear to be important factors influencing procedural success and one-year patency rates. Additionally, there are concerns regarding the potential clinical impact of stent fractures, reported at rates ranging from 12% to 37.2% at one year.
Despite the improved outcomes seen with newer Nitinol stent designs, the primary limitations of stenting in the superficial femoral artery are the use of multiple overlapping stents or long stents and the associated potential rate of stent fracture resulting reocclusion of the treated superficial femoral artery and clinical worsening of patients who in most cases are initially treated for disabling claudication.
Being able to preoperatively determine in which patients there are risk factors prognostically associated with a higher rate of fracture/reocclusion could represent a help for the operator in choosing the best therapeutic strategy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* adult patients (≥ 18 years) hospitalized in the Operating Units participating in the study and subjected to a recanalization/dilation and stenting procedure of the superficial femoral artery due to stenosis or obstruction of the same conditioning disabling claudication or critical ischemia of the lower limb (class 3-4-5-6 according to Rutherford).
Exclusion Criteria:
* minor patients (age \<18 years);
* patients who have not given their consent to participate in the study;
* Pregnant women.
Primary outcome measure(s)
Rate of Stenting failure (restenosis/occlusion/fracture) — 1 month determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.
Rate of Stenting failure (restenosis/occlusion/fracture) — 6 months determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.
Rate of Stenting failure (restenosis/occlusion/fracture) — 12 months determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.
Rate of Stenting failure (restenosis/occlusion/fracture) — 24 months determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.
Rate of Stenting failure (restenosis/occlusion/fracture) — 36 months determine the predictive capacity of a mathematical model developed by the LaBS (Laboratory of Biological Structure Mechanics), Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", of the Polytechnic of Milan to predict the fracture of a stent positioned in superficial femoral artery for the treatment of stenosis/obstruction of the same in adult patients suffering from obliterating arterial disease of the lower limbs.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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