Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
Key facts
- Who runs it
- W.L.Gore & Associates
- Where
- Caserta and Milan, ItalySee the 2 sitesAlso in 9 other countries, 35 sites
- Trial code
- Status
- Recruiting
- People taking part
- 1,500 people, planned
- Started
- 19 Jun 2025
- Expected to end
- Aug 2038
- Type of study
- Observational, 2 groups
- Treatments tested
- Endovascular
- Record updated
- 19 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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; The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable
Who cannot take part
- Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol; The term "study" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions)
- 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
Where in Italy
Also in 9 other countries, 35 sites
- AORN S.Anna e S. SebastianoCaserta, ItalyContact: Andrea MontaltoTaking people
- IRCCS Policlinico di MilanoMilan, ItalyContact: Santi Trimarchi, ProfTaking people
About the trial
What the trial wants to find out
An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.
The 2 groups in the trial
- Aneurysm/Other Isolated Lesion
Treatment: Endovascular
- Dissection
Treatment: Endovascular
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 19 August 2026