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RecruitingNCT05777460Updated Mar 18, 2025

Mid- and Long-term Outcomes of Custom-made Aortic Devices

An observational study in Aortic Diseases and Thoracic Aortic Aneurysm, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

Primary conditionAortic Aneurysm, ThoracicRegistry: Aortic DiseasesReclassifiedWhy we changed it
Registry
Aortic Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Aortic Aneurysm, Thoracic
Why
  1. The study's listed conditions name Aortic Aneurysm, Thoracic, a narrower term within Aortic Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.

02

Conditions studied

  • Aortic Diseases
  • Thoracic Aortic Aneurysm

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03

In context

Aortic Aneurysm, Thoracic Reclassified

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's planned enrollment of 60 is below the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Browse Fondazione Policlinico Universitario Agostino Gemelli IRCCS studies →

Compared within Aortic Aneurysm, Thoracic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All the patients that underwent Thoracic Endovascular Aortic Repair (TEVAR) in the period 2015-2023 with the Custom Relay® Multi-Feature™ Terumo Aortic will be included in the analysis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Thoracic Aortic Disease

Exclusion criteria

Exclusion Criteria:

  • Urgent/Emergent treatment
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • DeviceThoracic endovascular aortic repair (TEVAR)

    The TEVAR procedure involves the placement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the artery.

06

What researchers measure

Primary outcomes

  1. Overall Mortality

    Any death occurring during follow-up

    Time frame: 3 years

  2. Aortic-related mortality

    Any death occurring during follow-up and related to the procedure

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2020 (actual). Primary completion is estimated for Nov 2025, 61 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2023
First posted
Mar 21, 2023
StartActual
Oct 1, 2020
Primary completionEst.
Nov 1, 2025
CompletionEst.
Nov 1, 2027
Last update
Mar 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05777460
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
TINELLI GIOVANNI (Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 21, 2023
Start date
Oct 1, 2020
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Mar 18, 2025

Study contacts

Giovanni Tinelli
Contact
giovanni.tinelli@policlinicogemelli.it
‭+39 347 4864020‬

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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