Registry for GORE® TAG® Thoracic Branch Endoprosthesis
Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
This study is collecting information on how well the GORE® TAG® Thoracic Branch Endoprosthesis works and is tolerated by patients with vascular diseases over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | W.L.Gore & Associates Industry-sponsored |
| Locations | 20 sites (Vienna and 19 other locations) |
| Trial ID | NCT06507865 on ClinicalTrials.gov |
What this trial studies
This observational registry collects mid-term clinical follow-up data on the GORE® TAG® Thoracic Branch Endoprosthesis used in patients with vascular diseases. The study aims to evaluate the efficacy and safety of the device in real-world settings, with patient selection and treatment determined by physicians based on standard medical practices. Participants will attend regular follow-up visits and report any issues related to the device or surgery to their healthcare providers.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older who are being treated with the GORE® TAG® Thoracic Branch Endoprosthesis.
Not a fit: Patients who are unlikely to attend follow-up visits or are enrolled in concurrent studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of the GORE® TAG® Thoracic Branch Endoprosthesis for patients with aortic conditions.
How similar studies have performed: Other observational studies have successfully gathered real-world data on similar endovascular devices, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vienna and 19 other locations
- Medizinische Universität Wien — Vienna, Austria (Recruiting)
- Rigshospitalet University Hospital — Copenhagen, Denmark (Recruiting)
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Suspended)
- University of Heidelberg — Heidelberg, Germany (Active_not_recruiting)
- Universitätsklinikum Schleswig-Holstein — Kiel, Germany (Not_yet_recruiting)
- Universitätsklinikum Münster — Münster, Germany (Active_not_recruiting)
- Evangelismos General Hospital — Athens, Greece (Recruiting)
- Laiko General hospital of Athens — Athens, Greece (Active_not_recruiting)
- Policlinico di Sant'Orsola — Bologna, Italy (Active_not_recruiting)
- ASST Spedali Civili di Brescia — Brescia, Italy (Recruiting)
- IRCCS Ospedale Policlinico San Martino — Genova, Italy (Recruiting)
- AOU Padova — Padova, Italy (Not_yet_recruiting)
- Azienda Ospedaliera "G. Brotzu" — Selargius, Italy (Not_yet_recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
- Complejo Hospitalario Universitario de Vigo — Vigo, Spain (Withdrawn)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (Active_not_recruiting)
- Skane University Hospital — Malmö, Sweden (Active_not_recruiting)
- St Thomas' Hospital — London, United Kingdom (Not_yet_recruiting)
- St Mary's Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Gabrielle Valle Diekmann
- Email: gvalledi@wlgore.com
- Phone: +49 (0)174 690 0619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.