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Can frailty predict stent failure? new study investigates

NCT ID NCT07672249

Knowledge-focused Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tracks 98 people with peripheral artery disease who had a stent placed in their iliac artery. Researchers want to see which patients later develop serious limb complications, like needing another procedure or amputation. They will also check if frailty plays a role. The goal is to better predict and prevent these outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify patients at higher risk for complications after iliac stenting, leading to better follow-up care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. Results may not apply to all hospitals or patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

arteriosclerosis obliterans Chronic Limb-Threatening Ischemia intermittent vascular claudication Leriche syndrome limb ischemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortoiliac occlusive disease Chronic limb-threatening ischemia Intermittent claudication Peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Galeazzi Sant'Ambrogio Hospital

    RECRUITING

    Milan, Mi, 20157, Italy

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