Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

Launched by W.L.GORE & ASSOCIATES · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how well the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System works over a long period of time for patients with various vascular conditions affecting the aorta, such as aneurysms and dissections. Researchers are collecting data from patients treated with this device to see how it performs in everyday clinical settings over a follow-up period of up to ten years. The goal is to confirm that this type of treatment remains a good option for patients who need it.

To participate in this study, patients must be at least 18 years old and have provided consent to be part of the registry. They should be receiving the GORE® TAG® device as part of their treatment. It's important that participants can attend follow-up visits as required by the hospital's guidelines. The trial is not yet recruiting participants, so it is not open for enrollment at this time. If you or someone you know might be interested, it’s a good idea to talk to your healthcare provider for more information about eligibility and the potential benefits of participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
• • 2. Patient has been or is intended to be treated with an eligible registry device.\*
• • 3. 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, consent prior to the time of discharge for the index procedure is acceptable.
• Exclusion Criteria:
• • 1. 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.
• • 2. Patient with exclusion criteria required by local law.
• • 3. 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).