Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

Launched by W.L.GORE & ASSOCIATES · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the GORE® TAG® Thoracic Branch Endoprosthesis, a device used to treat certain vascular diseases like aortic aneurysms and dissections. The purpose of the trial is to gather information about how well this device works and how safe it is for patients over time after they have received it. This is an observational study, which means researchers will observe and collect data from patients who receive the device as part of their regular medical care, rather than providing any experimental treatment.

To participate in this trial, patients need to be at least 18 years old and must provide their consent or have a legal representative do so. They should be planning to receive the GORE® TAG® device as part of their treatment. However, patients who are unlikely to attend follow-up visits or who are involved in other similar studies within the past year may not be eligible. Throughout the study, participants will be monitored for their health and any issues related to the device, helping researchers understand its effectiveness and safety for future patients.

Gender

ALL

Eligibility 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.