NCT05777460

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Oct 2020Nov 2027

Study Start

First participant enrolled

October 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

5.1 years

First QC Date

March 9, 2023

Last Update Submit

March 15, 2025

Conditions

Aortic DiseasesThoracic Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

  • Overall Mortality

    Any death occurring during follow-up

    3 years

  • Aortic-related mortality

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

    3 years

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Thoracic Aortic Disease

You may not qualify if:

  • Urgent/Emergent treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

RECRUITING

MeSH Terms

Conditions

Aortic DiseasesAortic Aneurysm, Thoracic

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAortic AneurysmAneurysm

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Central Study Contacts

Giovanni Tinelli

CONTACT

‭+39 347 4864020‬giovanni.tinelli@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

October 1, 2020

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2027

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)