Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Predicting unstable carotid plaques using radiomics and biomechanics

Official title: Predicting High-Risk Carotid Plaque: Integrating radioMics and biomEchanics

Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT07877480 · Data updated 2026-11-12

This study tests a noninvasive model to identify unstable carotid plaques in adults at initial diagnosis who may be candidates for carotid surgery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment420 (estimated)
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Academic / other
Drugs / interventionsradiation
Locations1 site (Milan)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedSeptember 30, 2026
Study endsDecember 30, 2026
Registry record updatedOctober 16, 2026
Trial IDNCT07877480 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with significant carotid atherosclerosis (stenosis ≥70% ECST), eligible for carotid endarterectomy, and with available preoperative imaging.

Probably not a fit

Patients without significant plaques, those not indicated for surgery, or lacking preoperative imaging may not benefit from this predictive model.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will integrate radiomic features from imaging with biomechanical data to predict plaque instability in patients with significant carotid atherosclerosis. The study uses prospective–retrospective data and biological samples to develop a predictive model. The goal is to identify high-risk plaques in asymptomatic patients before any stroke occurs, complementing existing risk stratification methods. Eligible participants are adults with stenosis of 70% or more who are planned for carotid endarterectomy and have preoperative imaging. This work could guide earlier, targeted interventions and reduce stroke risk.

Why it matters

Potential benefit: If successful, the model could help doctors identify patients at higher risk of stroke so they can plan timely preventive treatment.

How similar studies have gone: Radiomics and biomechanical analyses have shown promise in characterizing plaque features, though integrating both for prediction in asymptomatic patients is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients ≥ 18 years of age;
* Affected by significant carotid atherosclerosis, whether symptomatic or asymptomatic (stenosis ≥ 70% according to ECST criteria).
* Candidates for carotid ATE surgery. The criteria provided by the SICVE and ESVS guidelines will be followed for indications for surgery;
* Preoperative imaging available;

Exclusion Criteria:

* Patients who have undergone previous carotid endarterectomy (ipsilateral to the affected side);
* Patients who have undergone previous neck surgery involving cervical lymph node dissection;
* Patients who have undergone previous neck radiation therapy;
* Lack of preoperative imaging;
* Patients unable to sign informed consent.

Where it's running

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milan, Italy
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.