RecruitingNot Applicable

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

Italy98 participantsStarted 2026-06-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Experiencing Major Adverse Limb Events (MALE) Within 12 Months

Timeframe: 12 months

Trial details

NCT IDNCT07672249

SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-01

Contact for this trial

Luca Galassi, MD

+393458013083 luca.galassi@unimi.it

View on ClinicalTrials.gov More Peripheral Arterial Disease trials