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

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study ID
NCT07672249
Status
Recruiting
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Conditions

  • Aortoiliac Occlusive Disease
  • Chronic Limb-Threatening Ischemia
  • Intermittent Claudication
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iliac stenting — PROCEDURE
    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 Details

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.

Key Dates

First listed
Jun 26, 2026
Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2026
Completion
Jul 16, 2026

Study Design

Enrollment
98 participants (estimated)

Primary Outcome Measure

Number of Participants Experiencing Major Adverse Limb Events (MALE) Within 12 Months [ Time Frame: 12 months ]

Central Contacts

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