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ACTIVE NOT RECRUITING
NCT06198920

Fatigue Behavior of Peripheral STENt of the Superficial Femoral Artery

Sponsor: IRCCS Policlinico S. Donato

View on ClinicalTrials.gov

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.

Official title: Atherosclerotic Pathology of the Superficial Femoral Arteries: Study and Patient-specific Prediction of the Fatigue Behavior of Peripheral STENt in Nitinol Via Mathematical Modeling. Prospective Enrollment

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2017-12-19

Completion Date

2026-12

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

PROCEDURE

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

Locations (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, Italy