Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

J
Joel Corvera, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
6 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Aortic Aneurysm, Vascular Disease
  • Age: 18 years - 100 years
  • Gender: All

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).

Updated on 24 Jul 2025. Study ID: ECRO-WLG-TGR-23-02TA, 26608
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only