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NCT06507865 | NOT YET RECRUITING | Aneurysm

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
Sponsor:

W.L.Gore & Associates

Brief Summary:

The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.

Condition or disease

Aneurysm

Dissection, Aortic

TAA Thoracoabdominal Aortic Aneurysm

Thoracic Aortic Aneurysm

Transection Aorta

Intervention/treatment

GORE® TAG® Thoracic Branch Endoprosthesis

Detailed Description:

The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions. Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
Official Title : Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2031-04
Estimated Study Completion Date : 2031-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature.
Exclusion Criteria
  • Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
  • Patient with exclusion criteria required by local law. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

Location Details

NCT06507865

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Austria,

Medical University of Vienna

Wien, Austria, A-1090

Not yet recruiting

Denmark,

Rigshospitalet University Hospital

Copenhagen, Denmark, 2100

Not yet recruiting

Germany,

Carl Gustav Carus University Hospital Dresden

Dresden, Germany, 01307

Not yet recruiting

Germany,

University of Heidelberg

Heidelberg, Germany, 69120

Not yet recruiting

Germany,

Schleswig-Holstein University Hospital

Like, Germany, 24105

Not yet recruiting

Germany,

Münster University Hospital

Muenster, Germany, 48149

Not yet recruiting

Greece,

Evangelismos General Hospital

Athens, Greece, 106 76

Not yet recruiting

Greece,

Laiko General Hospital of Athens

Athens, Greece, 11527

Not yet recruiting

Italy,

Sant'Orsola Polyclinic

Bologna, Italy, 40138

Not yet recruiting

Italy,

ASST Civil Spedali of Brescia

Brescia, Italy, 25123

Not yet recruiting

Italy,

IRCCS San Martino Polyclinic Hospital

Genova, Italy, 16132

Not yet recruiting

Italy,

AOU Padova

Padova, Italy, 35128

Not yet recruiting

Netherlands,

Amsterdam UMC

Amsterdam, Netherlands, 1105 AZ

Not yet recruiting

Netherlands,

Radboud UMC

Nijmegen, Netherlands, 6525 GA

Not yet recruiting

Spain,

Vigo University Hospital Complex

Vigo, Spain, 36312

Not yet recruiting

Spain,

Miguel Servet University Hospital

Zaragoza, Spain, 50009

Not yet recruiting

Sweden,

Skane University Hospital

Malmö, Sweden, 205 02

Not yet recruiting

United Kingdom,

St Thomas' Hospital

London, United Kingdom, SE1 7EH

Not yet recruiting

United Kingdom,

St Mary's Hospital

London, United Kingdom, W2 1NY