Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Iliac stenting: clinical assessment of symptoms, including intermittent claudication, rest pain, or wound status in patients with chronic limb-threatening ischemia (CLTI); physical examination with peripheral pulse assessment and, when available, ankle-brachial index (ABI) measurement; duplex ultrasound imaging of the treated iliac segment and downstream arterial circulation, performed according to institutional surveillance protocols or clinical indication; computed tomography angiography (CTA) or other cross-sectional imaging only in cases of suspected in-stent restenosis, occlusion, or clinical deterioration; documentation of clinically relevant adverse events, including Major Adverse Limb Events (MALE), reinterventions, amputations, and all- cause mortality, retrieved from outpatient records and the institutional electronic health record system.

Study summary

Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia. Endovascular iliac artery stenting has become the preferred treatment strategy for most iliac lesions, including complex TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions, owing to high technical success rates and lower perioperative morbidity compared with open surgical reconstruction.

Despite widespread adoption of endovascular treatment, available evidence regarding predictors of major adverse limb events (MALE) after iliac artery stenting remains limited, particularly in unselected real-world populations with substantial comorbidity burden. Patient-related factors, including frailty, may contribute to post-procedural outcomes in addition to lesion-related characteristics.

This retrospective single-center cohort study will evaluate clinical outcomes following endovascular iliac artery stenting in consecutive adult patients treated at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study will assess the occurrence of major adverse limb events (MALE), primary patency, peri-procedural complications, target lesion revascularization, restenosis or occlusion, and all-cause mortality. Clinical, anatomical, and procedural factors associated with adverse limb outcomes, including frailty assessed by the modified five-item Frailty Index (mFI-5), will also be investigated.

Eligibility

Primary outcome measure(s)

• Number of Participants Experiencing Major Adverse Limb Events (MALE) Within 12 Months — 12 months
  MALE is defined as a composite endpoint including: acute limb ischaemia requiring intervention, major amputation (above or below knee), or surgical/endovascular re-intervention on the target iliac vessel. Results will be reported as the number and proportion of participants experiencing at least one MALE event within 12 months of the index procedure. Independent predictors will be identified by multivariable Cox regression, including frailty (mFI-5), lesion complexity (TASC II class), stent type, and cardiovascular comorbidities.

Trial sites (1)

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