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Fatigue Behavior of Peripheral STENt of the Superficial Femoral Artery

NCT06198920 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-04-07

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2020-03-28
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06198920 on ClinicalTrials.gov