Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

W.L. Gore & Associates

Status: Not yet enrolling

Conditions: Aneurysm; Dissection, Aortic; Transection Aorta; Thoracic Aortic Aneurysm; TAA Thoracoabdominal Aortic Aneurysm

Treatments: Device: GORE® TAG® Thoracic Branch Endoprosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT06507865

TGR 23-02TB

Details and patient eligibility

About

The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.

Full description

The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, 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: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

GORE® TAG® Thoracic Branch Endoprosthesis

Description:

Patients treated with the TBE Device

Treatment:

Device: GORE® TAG® Thoracic Branch Endoprosthesis