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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05777460
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 49
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Diseases; Thoracic Aortic Aneurysm	Device: Thoracic endovascular aortic repair (TEVAR)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2024

Outcome Measures

Primary Outcome Measures

1. Overall Mortality [3 years]

   Any death occurring during follow-up

2. Aortic-related mortality [3 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Thoracic Aortic Disease

Exclusion Criteria:

• Urgent/Emergent treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM	Italy	00167

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TINELLI GIOVANNI, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05777460
• Other Study ID Numbers: 2992
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 21, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases

Study Results

No Results Posted as of Mar 21, 2023