NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
| NCT ID | NCT06658730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | W.L.Gore & Associates |
| Condition | Vascular Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2038-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2025-06-19 with a primary completion date of 2038-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Ali Azizzadeh, M.D.
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT06658730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06658730 currently recruiting?
Yes, NCT06658730 is actively recruiting participants. Contact the research team at ahoedt@wlgore.com for enrollment information.
Where is the NCT06658730 trial being conducted?
This trial is being conducted at Tucson, United States, Los Angeles, United States, Los Angeles, United States, Stanford, United States and 11 additional locations.
Who is sponsoring the NCT06658730 clinical trial?
NCT06658730 is sponsored by W.L.Gore & Associates. The principal investigator is Ali Azizzadeh, M.D. at Cedars-Sinai Medical Center. The trial plans to enroll 1,500 participants.