Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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