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

NCT07672249 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2026-06-30

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-16
Primary Completion
2026-07-01
Completion
2026-07-16

Countries

  • Italy

Study Locations

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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 NCT07672249 on ClinicalTrials.gov