- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777460
Mid- and Long-term Outcomes of Custom-made Aortic Devices
March 9, 2023 updated by: TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft
This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Giovanni Tinelli
- Phone Number: +39 347 4864020
- Email: giovanni.tinelli@policlinicogemelli.it
Study Locations
-
-
RM
-
Roma, RM, Italy, 00167
- Recruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS
-
Contact:
- Giovanni Tinelli
- Phone Number: 0039 0630157205
- Email: giovanni.tinelli@policlinicogemelli.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Thoracic Aortic Disease
Exclusion Criteria:
- Urgent/Emergent treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Mortality
Time Frame: 3 years
|
Any death occurring during follow-up
|
3 years
|
Aortic-related mortality
Time Frame: 3 years
|
Any death occurring during follow-up and related to the procedure
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Anticipated)
November 1, 2023
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
March 9, 2023
First Submitted That Met QC Criteria
March 9, 2023
First Posted (Actual)
March 21, 2023
Study Record Updates
Last Update Posted (Actual)
March 21, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Bolton MedicalCompletedAortic Aneurysm | Aortic Aneurysm, Thoracic | Aorta, Thoracic Pathologies
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Guangdong Provincial People's HospitalThe First Affiliated Hospital of Guangzhou Medical University; Shenzhen People... and other collaboratorsRecruitingIntramural HematomaChina
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Cook Group IncorporatedWilliam Cook Europe; MED Institute, Incorporated; William Cook AustraliaCompletedThoracic Aortic AneurysmUnited States, Italy, Canada
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Stanford UniversityCompleted
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First Affiliated Hospital of Zhejiang UniversityActive, not recruitingAortic Diseases | Aortic Dissection | Aortic Aneurysm, Thoracic | Coarctation of Aorta | Hematoma; AortaChina
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