Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

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

Keywords

ClinConnect Summary

This clinical trial is studying the outcomes of two specific devices used to treat abdominal aortic aneurysms (AAA): the GORE® EXCLUDER® Conformable AAA Endoprosthesis and the GORE® EXCLUDER® Iliac Branch Endoprosthesis. An AAA is a bulge in the aorta, the main blood vessel that supplies blood to the body, which can be dangerous if it ruptures. The trial aims to collect information about how well these devices work and the long-term results for patients over a period of ten years after their procedure.

To participate in this study, you must be at least 18 years old and have given your consent. You should also be planned to receive one of the devices being studied. However, if you are unlikely to attend follow-up visits or are involved in another clinical trial, you may not be eligible. Participants will be monitored regularly to track their health and the performance of the devices. This research is important as it will help improve treatment options and care for patients with AAA in the future.

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.
• 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 drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.