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

NCT07672249 | Recruiting

• 1 other identifier: PREMISE-ILIAC
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Peripheral Arterial Disease; Iliac Artery Stenting; Endovascular Revascularization

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Major Adverse Limb Events (MALE) Within 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.

  12 months

Secondary Outcomes (5)

• Primary Patency of the Treated Iliac Artery Segment

  12 months

• Number of Participants With Peri-Procedural Complications

  30 days

• All-Cause Mortality

  12 months

• Freedom From Target Lesion Revascularization (TLR)

  12 months

• Number of Participants With Iliac Artery Restenosis or Occlusion

  12 months

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients (≥18 years), both male and female, undergoing endovascular stenting for stenotic or occlusive disease of the common and/or external iliac arteries (CIA/EIA) at IRCCS Galeazzi-Sant'Ambrogio, Milan, between January 2023 and May 2025, will be retrospectively included. Lesions will be classified according to TASC II, with an expected predominance (\~70%) of complex (C-D) lesions.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Galeazzi Sant'Ambrogio Hospital

Milan, Mi, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Signs and Symptoms

Central Study Contacts

Luca Galassi, MD

CONTACT

+393458013083; luca.galassi@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 26, 2026
• Study Start: June 16, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 16, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

IT (1)