Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance (TGR 23-02TA)

W.L. Gore & Associates

Status: Not yet enrolling

Conditions: Intramural Hematoma; Transection Aorta; Aneurysm Dissecting; Aneurysm Thoracic; Vascular Disease; Dissection of Aorta; Dissection Aortic Aneurysm; Dissection

Treatments: Device: Endovascular

Study type: Observational

Funder types: Industry

Identifiers

NCT06658730

TGR 23-02TA (Other Identifier)

Details and patient eligibility

About

An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.

Enrollment: 1,500 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.

   • 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).

Trial design

1,500 participants in 2 patient groups

Aneurysm/Other Isolated Lesion

Treatment:

Device: Endovascular

Dissection

Treatment:

Device: Endovascular