NCT05479305 Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
| NCT ID | NCT05479305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ceric Sàrl |
| Condition | Penetrating Ulcer of Aorta |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2024-11 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft. Clinical utility measures throughout the procedure and until discharge will be assessed
Eligibility Criteria
Inclusion Criteria: TAA/PAU (Thoracic Aortic Aneurysms and Penetrating Ulcers): 1. Subject is at least 18 years of age. 2. Subject understands and has signed an Informed Consent approved by the Sponsor for this study. 3. Subject must be considered a candidate for revascularisation of BT, LCCA and LSA. 4. Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA. 5. Subject has a TAA/PAU which is: * a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is \> 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR * a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in diameter, or symptomatic) 6. Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm 7. Subject has no thrombus in the proximal neck 8. Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm 9. Subject has a non-diseased LSA which is eligible for stent-grafting 10. Subject has sufficient