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Intraluminal ThrombosisTRACENCT07492433

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

An observational study of Intraluminal Thrombosis and Tevar, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intraluminal Thrombosis, Tevar, FET
How many people
800 participants
Where
1 siteItaly
Study dates
1 Apr 2026to 30 Sep 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients previously treated with TEVAR or FET

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

Other trials in Italy

About this study

Official title: 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.

Keywords
Intraluminal thrombosis, FET, TEVAR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07492433
Study groupRoleWhat they receive
TEVAR WITH ILTPATIENTS TREATED WITH TEVAR THAT SHOW AN ILT AT FOLLOW UP
FET WITH ILTPATIENTS TREATED WITH TEVAR THAT SHOW AN ILT AT FOLLOW UP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence (percentage on total case) of postoperative ILT in patients undergoing FET or TEVAR

    Measured: FROM POSTOP UP TO 15 YEARS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start1 Apr 2026
  3. Primary completion31 Jul 2026
  4. Study completion30 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07492433
Sponsor's protocol ID
6507
Acronym
TRACE
Status last verified
Nov 2026
First submitted
9 Mar 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Intraluminal Thrombosis and Tevar, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence (percentage on total case) of postoperative ILT in patients undergoing FET or TEVAR (time frame: FROM POSTOP UP TO 15 YEARS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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