Long-term outcomes after GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

An observational, prospective post-market registry will collect mid- and long-term clinical data on patients treated with the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL as part of routine TEVAR care. Enrolled adults (≥18) who receive the device at participating centers will be followed according to local standard-of-care schedules, with planned follow-up out to ten years. Data collected will include procedural details, device performance, aortic-related outcomes, complications, and survival. The registry aims to characterize real-world durability and safety of the device across multiple centers and patient presentations.

Why it matters

Who can join: the full rules

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 due to emergent situation, 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).

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Leland Stanford Junior University
  Stanford, California, United States Recruiting
• University of Florida - Gainesville
  Gainesville, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Ali Azizzadeh, M.D. — Cedars-Sinai Medical Center
• Study coordinator: Ashley Hoedt, MS
• Email: ahoedt@wlgore.com
• Phone: +1 928-864-3987

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.