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NCT05777460 Clinical Trial

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

Aortic Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05777460
Other study ID # 2992
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date November 1, 2024

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Giovanni Tinelli
Phone ?+39 347 4864020?
Email giovanni.tinelli@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date November 1, 2024
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Thoracic Aortic Disease Exclusion Criteria: - Urgent/Emergent treatment

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Thoracic 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.

Locations
Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Mortality Any death occurring during follow-up 3 years
Primary Aortic-related mortality Any death occurring during follow-up and related to the procedure 3 years
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