Predictors of Major Adverse Limb Events After Iliac Artery Stenting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, single-center observational study of adults undergoing endovascular iliac artery stenting. It aims to identify patient- and lesion-related factors that predict Major Adverse Limb Events in a real-world population with substantial comorbidity. Outcomes will include limb-related adverse events after the procedure and will be analyzed in relation to baseline characteristics and imaging findings. The study uses data from routine clinical care at a high-volume Italian center to generate insights applicable to everyday practice. No interventional assignment is made; the focus is on observational associations in real-world care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adult patients aged ≥18 years, of both male and female sex

* Presence of haemodynamically significant stenosis or occlusion of the common iliac artery (CIA) and/or external iliac artery (EIA), documented by computed tomography angiography, magnetic resonance angiography, or diagnostic angiography
* Symptomatic peripheral artery disease, including lifestyle-limiting intermittent claudication (Rutherford category 2-3) or chronic limb- threatening ischaemia (CLTI; Rutherford category 4-6), refractory to optimal medical therapy
* Treatment with endovascular iliac artery stenting (covered or uncovered; balloon-expandable or self-expanding devices) as the primary revascularisation strategy
* De novo iliac lesions only
* Availability of complet

Exclusion Criteria:

Primary open surgical revascularisation of the iliac axis (e.g., aorto- bifemoral bypass or endarterectomy).

* Previous stenting of the target iliac segment (in-stent restenosis cases excluded).
* Aorto-iliac aneurysmal disease as the primary indication for treatment (including EVAR or fenestrated endografts).
* Hybrid procedures with concomitant infrainguinal bypass surgery.
* Incomplete clinical, procedural, or follow-up data preventing assessment of study endpoints.
* Loss to follow-up without documented clinical outcomes.

Where it's running

• IRCCS Galeazzi Sant'Ambrogio Hospital
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Luca Galassi, MD
• Email: luca.galassi@unimi.it
• Phone: +393458013083

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.