- Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance — Recruiting • Cardiology / Cardiovascular • NCT06658730.
- What is being tested: Long-term safety and performance of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System in treating thoracic aortic disease, with follow-up data collected over ten years through routine clinical practice.
- Patient eligibility overview: Adults with thoracic aortic pathology suitable for endovascular repair who receive the GORE® TAG® Conformable device as standard clinical treatment, followed prospectively in this multi-regional registry.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
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- Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
- Patient has been or is intended to be treated with an eligible registry device.*
- 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.