Risk Factors, Incidence, and Clinical Impact of Intraluminal Thrombosis Following FET and TEVAR (TRACE)

March 19, 2026 updated by: Santi Trimarchi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Risk Factors, Incidence, and Clinical Impact of Intraluminal Thrombosis Following the FRozen ElephAnt Trunk (FET) ProCedure and Thoracic Endovascular Repair (TEVAR): A Multicenter rEtrospective Cohort Study

Intraluminal thrombosis (ILT) is a significant but underexplored complication in aortic interventions. It is defined as the formation of thrombosis, partially or totally obstructing the lumen, in the surgically treated, stented, or native aorta. In cases of Frozen Elephant Trunk interventions for which are performed regulary for type A dissections, or pathologies such as penetrating aorting ulcers or aneurysm of the distal arch or proximal descending, an ILT can occur early in the postoperative traject and have severe consequences. A recent systematic review and meta-analysis from our group (abstract attached as Annex 1; manuscript pending) analyzed data from 825 patients. and estimated a pooled incidence of ILT of 8.6% [95% CI: 5.7-12.9]. The included studies reported ILT rates ranging from 6.2% to 16.8% (1-4). Patients with ILT had significantly higher risks of dialysis (43% vs. 16%) and mortality (25% vs. 8%). Risk factors included female gender, older age, and concomitant aortic valve replacement. Despite these findings, the underlying pathophysiology and management strategies for ILT in FET remain poorly defined Intraluminal thrombosis (ILT) is a recognized but poorly studied complication following endovascular thoracic aortic repair (TEVAR). Case reports have described its occurrence, particularly in patients with blunt aortic trauma (5-14), and one study suggested a higher risk of intraluminal narrowing among female patients, associated with increased reoperation rates (15). However, no reliable data exist regarding the overall incidence, risk factors, or clinical outcomes of ILT following TEVAR.

A recent systematic review conducted by our group (abstract attached as Annex 2; manuscript pending) identified 10 case reports and three retrospective studies reporting highly variable ILT rates (5-14, 16-18). A study, focusing on blunt aortic trauma patients, found an ILT incidence of 20.6% in a cohort of 34 patients, while another study observed 2 cases in 97 patients (2.06%), and a third study reported 0 cases in 11 patients (0%). The lack of consistent epidemiological data highlights the necessity of a multicenter cohort study to establish a reliable incidence estimate and investigate potential risk factors and clinical outcomes.

This study aims to fill the knowledge gap through a multicenter analysis involving patients treated with FET and TEVAR. By identifying risk factors for ILT, describing related outcomes, and evaluating management strategies, the ultimate goal is to improve clinical care and outcomes for patients undergoing these procedures.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients undergoing elective and emergency FET and TEVAR procedures between Jan 2010 and June 2025.

Description

Inclusion Criteria:

  • age ≥18 years
  • males and females
  • presence of pre- and post-operative CT imaging

Exclusion Criteria:

  • Patients previously treated with TEVAR or FET

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TEVAR WITH ILT
PATIENTS TREATED WITH TEVAR THAT SHOW AN ILT AT FOLLOW UP
FET WITH ILT
PATIENTS TREATED WITH TEVAR THAT SHOW AN ILT AT FOLLOW UP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence (percentage on total case) of postoperative ILT in patients undergoing FET or TEVAR
Time Frame: FROM POSTOP UP TO 15 YEARS
FROM POSTOP UP TO 15 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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