Actively Recruiting
Study of Factors Influencing Limb Outcomes After Endovascular Iliac Artery Stenting in Adults with Peripheral Arterial Disease
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2026-06-30
98
Participants Needed
1
Research Sites
2 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates peripheral arterial disease affecting the iliac arteries, focusing on clinical outcomes after endovascular iliac artery stenting. The study aims to understand factors influencing major adverse limb events MALE in adults treated at IRCCS Galeazzi-SantAmbrogio Hospital in Milan, Italy. It addresses the gap in real-world data on MALE predictors, especially considering patient frailty and comorbidities. Participants underwent endovascular stenting for de novo stenosis or occlusion of the common or external iliac arteries between January 2023 and May 2025. The study retrospectively reviews medical records, imaging, and vascular registries to evaluate outcomes such as MALE, primary artery patency, peri-procedural complications, revascularization needs, restenosis, and mortality. Frailty is assessed using the modified five-item Frailty Index mFI-5 alongside clinical and anatomical factors. During follow-up, clinical surveillance includes outpatient visits, ankle-brachial index measurements, duplex ultrasound, and imaging as needed. Researchers will analyze limb event-free survival over 12 months and other outcomes like all-cause mortality and target lesion revascularization. Data analysis employs survival and regression models to identify factors linked to adverse limb outcomes in this unselected patient group.
CONDITIONS
Brief Title
Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study
Research Team
L
Luca Galassi, MD
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