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

W.L. Gore & Associates

Status: Enrolling

Conditions: AAA - Abdominal Aortic Aneurysm

Study type: Observational

Funder types: Industry

Identifiers

NCT06218875

TGR 23-02AA

Details and patient eligibility

About

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

Full description

The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.

Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,500 participants in 2 patient groups

GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device)

Description:

Patients treated with the EXCC Device

GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device)

Description:

Patients treated with the IBE Device