ClinicalTrials.gg
Not yet recruitingNCT06276413REBRAUpdated Feb 26, 2024

REgistRy BRAnch goRE EndopRosthEsis

An observational study in Aortic Aneurysm, Thoracic and Aortic Dissection, sponsored by University Hospital Padova. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by University Hospital Padova · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Aortic Aneurysm, Thoracic
  • Aortic Dissection

Keywords

  • endograft
03

In context

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's planned enrollment of 50 is below the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

University Hospital Padova is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • less than 18 years
  • allergy to endograft components
  • patients receiving other types of arch endografts
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • DeviceGORE TAG Thoracic Branch Endoprosthesis

    deployment of the GORE TAG Thoracic Branch Endoprosthesis fro thoraci aorta pathologies

06

What researchers measure

Primary outcomes

  1. early mortality

    mortality related to the intervention within 30 days

    Time frame: 30 days

  2. device stability

    freedom from related mortality, reintervention, type 1a endoleak during follow-up

    Time frame: 5 years

  3. 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

    Time frame: 30 days

Secondary outcomes

  1. early major adverse events

    stroke, spinal cord ischemia, vascular complications, cardiac complications, respiratory insufficiency, early reintervention, acute kidney injury

    Time frame: 30 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06276413
Lead sponsor
University Hospital Padova
Responsible party
Michele Piazza (MD, University Hospital Padova) — Principal investigator
First posted
Feb 26, 2024
Start date
Mar 1, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Feb 26, 2024

Study contacts

Michele Antonello, PhD
Contact
michele.antonello.1@unipd.it
0498212636

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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