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

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

W.L.Gore & Associates · NCT06658730

This registry will follow adults who receive the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL after TEVAR to see how they do over ten years.

Quick facts

Study typeObservational
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorW.L.Gore & Associates (industry)
Locations34 sites (Tucson, Arizona and 33 other locations)
Trial IDNCT06658730 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (18+) treated or planned to be treated with the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL for descending thoracic aortic aneurysm, dissection, or related lesions who can provide consent and attend routine follow-up are ideal candidates.

Not a fit: Patients who are not treated with the GORE TAG device, cannot comply with follow-up, or are participating in conflicting investigational studies may not receive benefit from registry participation.

Why it matters

Potential benefit: If successful, the registry could confirm the long-term durability and safety of the GORE TAG device and help guide clinician and patient decisions on selection and follow-up after TEVAR.

How similar studies have performed: Endovascular repair with devices like the GORE TAG has substantial supporting literature and prior post-market registries showing favorable mid-term outcomes, though device-specific 10-year data are relatively limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Tucson, Arizona and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.