Aortic Aneurysm, ThoracicREBRANCT06276413
REgistRy BRAnch goRE EndopRosthEsis
An observational study of Aortic Aneurysm, Thoracic and Aortic Dissection, run by University Hospital Padova at 1 site in Italy.
Trial summary
Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic, Aortic Dissection
- What is being tested?
- GORE TAG Thoracic Branch Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 Dec 2030
- How long will I take part?
- 5 Years
- 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 consecutive patients treated with the Gore TAG thoracic branched endograft in the participating centers
Who may be able to join
- patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies
Who cannot join
- less than 18 years
- allergy to endograft components
- patients receiving other types of arch endografts
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
Vascular and Endovascular Clinic - Padova University
Padova, 35020
Michele Piazza, Pr, 3498644688, michele.piazza@unipd.it
About this study
Official title: Registry on Gore Branch Endoprosthesis
Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis
Read the detailed description
This is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the Gore thoracic branched endoprosthesis.
Inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.
- Conditions
- Aortic Aneurysm, Thoracic, Aortic Dissection
- Being tested
- GORE TAG Thoracic Branch Endoprosthesis
- Keywords
- endograft
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE TAG Thoracic Branch EndoprosthesisDevice
deployment of the GORE TAG Thoracic Branch Endoprosthesis fro thoraci aorta pathologies
What is being measured
The primary outcome is the main question the study is designed to answer.
early mortality
mortality related to the intervention within 30 days
Measured: 30 days
device stability
freedom from related mortality, reintervention, type 1a endoleak during follow-up
Measured: 5 years
technical success
succesful deployment of all endograft components at the intended site with complete aneurysm exclusion, without surgical conversion, type Ia/III endoleak, kink, stenosis, graft occlusion
Measured: 30 days
Secondary outcomes (1)
early major adverse events
stroke, spinal cord ischemia, vascular complications, cardiac complications, respiratory insufficiency, early reintervention, acute kidney injury
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Piazza, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276413
- Sponsor's protocol ID
- REBRA
- Other IDs
- REBRA
- Acronym
- REBRA
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry on Gore Branch Endoprosthesis
- ClinicalTrials.gov ID
- NCT06276413
- Acronym / sponsor ID
- REBRA / REBRA
- Conditions
- Aortic Aneurysm, Thoracic, Aortic Dissection
- Keywords
- endograft
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Feb 2024 (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.
Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis
Detailed description
This is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the Gore thoracic branched endoprosthesis.
Inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients treated with the Gore TAG thoracic branched endograft in the participating centers
Key inclusion criteria (1 listed)
- patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies
Key exclusion criteria (3 listed)
- less than 18 years
- allergy to endograft components
- patients receiving other types of arch endografts
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 |
|---|---|---|
| GORE TAG Thoracic Branch Endoprosthesisdeployment of the GORE TAG Thoracic Branch Endoprosthesis fro thoraci aorta pathologies | Device | – |
Primary outcome
early mortality
Time frame: 30 days
mortality related to the intervention within 30 days
device stability
Time frame: 5 years
freedom from related mortality, reintervention, type 1a endoleak during follow-up
technical success
Time frame: 30 days
succesful deployment of all endograft components at the intended site with complete aneurysm exclusion, without surgical conversion, type Ia/III endoleak, kink, stenosis, graft occlusion
1 secondary outcome
early major adverse events
Time frame: 30 days
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 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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 Aneurysm, Thoracic and Aortic Dissection, run by University Hospital Padova 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 3 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: opening soon, as of the sponsor's last update on 26 Feb 2024. 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 Michele Antonello, PhD (0498212636, michele.antonello.1@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early mortality (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.