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Recruiting

NCT Number: NCT05777460

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

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

Recruiting

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Key information

Conditions

Aortic Diseases Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Cardiovascular Diseases Thoracic Aortic Aneurysm Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

Location status: Recruiting

Location contact

Giovanni Tinelli

CONTACT

[email protected]

0039 0630157205

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Thoracic Aortic Disease

Exclusion criteria

  • Urgent/Emergent treatment

Treatment and study plan

Thoracic endovascular aortic repair (TEVAR)

Device

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.

Primary outcomes

  1. Overall Mortality

    Time frame: 3 years

    Any death occurring during follow-up

  2. Aortic-related mortality

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Tinelli

CONTACT

[email protected]

‭+39 347 4864020‬

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Mar 21, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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