Actively Recruiting

Age: 18Years +
All Genders
ID06507865

Characterization of Mid-term Post Market Clinical Follow Up of GORE TAG Thoracic Branch Endoprosthesis in Aortic Arch and Descending Aorta Interventions

Led by W.L.Gore & Associates · Updated on 2025-05-09

200

Participants Needed

20

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study collects mid-term post-market clinical follow-up data on the GORE4 TAG4 Thoracic Branch Endoprosthesis, a device used in patients with vascular diseases such as thoracic aortic aneurysm and aortic dissection. The study aims to evaluate questions about the device's efficacy and safety when used according to standard medical practice. Participants in this registry are patients treated with the GORE4 TAG4 Thoracic Branch Endoprosthesis device. Treatment decisions and patient selection are made by physicians based on routine clinical care, without specific requirements imposed by the study sponsor. Patients will have regular follow-up visits as determined by their surgeons and report any device or surgery-related issues during these visits. Throughout the study, participants will undergo assessments during scheduled visits as requested by their surgeon. Researchers will track outcomes such as technical success of device deployment, mortality related to the treated lesion, device migration, stroke, paraplegia, renal function changes, and need for further interventions up to two years after surgery. Additional safety events like bleeding, ischemia, and false lumen status will also be monitored. Participant involvement continues as long as standard care follow-up is maintained, with data collection aligned with routine clinical visits.

CONDITIONS

Brief Title

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient or legally authorized representative provides written consent according to local requirements
  • Patient has been or is intended to be treated with the GORE TAG Thoracic Branch Endoprosthesis device
  • Patient is 18 years of age or older at the time of consent
Not Eligible

You will not qualify if you...

  • Patient unlikely to attend standard follow-up visits as per site guidelines
  • Patient excluded by local law
  • Patient currently enrolled in or planning to enroll in another drug or device study within 12 months
  • Patient enrolled in another Together Registry module protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants receive the GORE® TAG® Thoracic Branch Endoprosthesis device as part of routine clinical care for thoracic vascular disease.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants who undergo routine care are observed with regular scheduled visits as requested by their surgeon to monitor device performance and health status.

Regular visits as requested by surgeon

Trial Site Locations

Total: 20 locations

1

Medizinische Universität Wien

Vienna, Austria, A-1090

Actively Recruiting

2

Rigshospitalet University Hospital

Copenhagen, Denmark, 2100

Actively Recruiting

3

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 01307

Suspended

4

University of Heidelberg

Heidelberg, Germany, 69120

Active, Not Recruiting

5

Universitätsklinikum Schleswig-Holstein

Kiel, Germany, 24105

Not Yet Recruiting

6

Universitätsklinikum Münster

Münster, Germany, 48149

Active, Not Recruiting

7

Evangelismos General Hospital

Athens, Greece, 106 76

Actively Recruiting

8

Laiko General hospital of Athens

Athens, Greece, 11527

Active, Not Recruiting

9

Policlinico di Sant'Orsola

Bologna, Italy, 40138

Active, Not Recruiting

10

ASST Spedali Civili di Brescia

Brescia, Italy, 25123

Actively Recruiting

11

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Actively Recruiting

12

AOU Padova

Padova, Italy, 35128

Not Yet Recruiting

13

Azienda Ospedaliera "G. Brotzu"

Selargius, Italy, 09047

Not Yet Recruiting

14

Amsterdam UMC

Amsterdam, Netherlands, 1105 AZ

Actively Recruiting

15

Radboud UMC

Nijmegen, Netherlands, 6525 GA

Actively Recruiting

16

Complejo Hospitalario Universitario de Vigo

Vigo, Spain, 36312

Withdrawn

17

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Active, Not Recruiting

18

Skane University Hospital

Malmö, Sweden, 205 02

Active, Not Recruiting

19

St Thomas' Hospital

London, United Kingdom, SE1 7EH

Not Yet Recruiting

20

St Mary's Hospital

London, United Kingdom, W2 1NY

Not Yet Recruiting

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Research Team

G

Gabrielle Valle Diekmann

D

Daniele Frangioni

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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