Aortic DiseasesNCT05777460
Mid- and Long-term Outcomes of Custom-made Aortic Devices
An observational study of Aortic Diseases and Thoracic Aortic Aneurysm, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases, Thoracic Aortic Aneurysm
- What is being tested?
- Thoracic endovascular aortic repair (TEVAR)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Thoracic Aortic Disease
Who cannot join
- Urgent/Emergent treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00167
Giovanni Tinelli, 0039 0630157205, giovanni.tinelli@policlinicogemelli.it
About this study
Official title: 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.
- Conditions
- Aortic Diseases, Thoracic Aortic Aneurysm
- Being tested
- Thoracic endovascular aortic repair (TEVAR)
- Medical subject headings
- Aortic Diseases, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mortality
Any death occurring during follow-up
Measured: 3 years
Aortic-related mortality
Any death occurring during follow-up and related to the procedure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Oct 2020
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777460
- Sponsor's protocol ID
- 2992
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sica S, Pratesi G, Rossi G, Ferraresi M, Lovato L, Volpe P, Fadda GF, Ferri M, Rizza A, D'Oria M, Micheli R, Tshomba Y, Tinelli G; OSCAR (prOximal Sealing aortiC ARch) Collaborative Study Group. Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft. J Vasc Surg. 2024 Nov;80(5):1317-1325.e2. doi: 10.1016/j.jvs.2024.07.086. Epub 2024 Jul 26.
PubMed 39069017
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft
- ClinicalTrials.gov ID
- NCT05777460
- Acronym / sponsor ID
- 2992
- Conditions
- Aortic Diseases, Thoracic Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Thoracic Aortic Disease
Key exclusion criteria (1 listed)
- Urgent/Emergent treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Overall Mortality
Time frame: 3 years
Any death occurring during follow-up
Aortic-related mortality
Time frame: 3 years
Any death occurring during follow-up and related to the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 39069017Sica S, Pratesi G, Rossi G, Ferraresi M, Lovato L, Volpe P, Fadda GF, Ferri M, Rizza A, D'Oria M, Micheli R, Tshomba Y, Tinelli G; OSCAR (prOximal Sealing aortiC ARch) Collaborative Study Group. Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft. J Vasc Surg. 2024 Nov;80(5):1317-1325.e2. doi: 10.1016/j.jvs.2024.07.086. Epub 2024 Jul 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Diseases and Thoracic Aortic Aneurysm, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Tinelli (+39 347 4864020, giovanni.tinelli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Mortality (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05777460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.