REgistRy BRAnch goRE EndopRosthEsis (REBRA)

February 16, 2024 updated by: Michele Piazza, University Hospital Padova

Registry on Gore Branch Endoprosthesis

Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

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

Study Locations

  • Italy
      • Padova, Italy, 35020
        • Vascular and Endovascular Clinic - Padova University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients treated with the Gore TAG thoracic branched endograft in the participating centers

Description

Inclusion Criteria:

  • patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies

Exclusion Criteria:

  • less than 18 years
  • allergy to endograft components
  • patients receiving other types of arch endografts

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
early mortality
Time Frame: 30 days
mortality related to the intervention within 30 days
30 days
device stability
Time Frame: 5 years
freedom from related mortality, reintervention, type 1a endoleak during follow-up
5 years
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early major adverse events
Time Frame: 30 days
stroke, spinal cord ischemia, vascular complications, cardiac complications, respiratory insufficiency, early reintervention, acute kidney injury
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBRA (Registry Identifier: REBRA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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