Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
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
∙ TAA/PAU (Thoracic Aortic Aneurysms and Penetrating Ulcers):
• Subject is at least 18 years of age.
• Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
• Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.
• Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.
• 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)
• Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm
• Subject has no thrombus in the proximal neck
• Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm
• Subject has a non-diseased LSA which is eligible for stent-grafting
⁃ Subject has sufficient landing zone within the LSA to accommodate the stent-graft without occlusion of any significant vessels
⁃ Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories.
⁃ Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
⁃ Subject is affiliated with the social security system
∙ TBAD(Type B Dissections) and Residual dissection after Type A repair:
• Subject is at least 18 years of age.
• Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
• a) Subject has a degenerative aortic arch aneurysm which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or b) Subject has a complicated TBAD (acute, subacute or chronic) which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or c) Subject has a complicated residual dissection after replacement of the ascending aorta for type A aortic dissection which will require coverage of the LSA and extension of the proximal seal zone to zone 0
• Subject has a healthy, non-diseased (without thrombus) aortic proximal seal zone of at least 20 mm
• Subject has a healthy, non-diseased (without thrombus) aortic distal seal zone of at least 20 mm
• Subject has a maximum diameter of the distal ascending aorta just above the BT of 40 mm
• Subject has a non-diseased aortic diameter between 28 mm to 42 mm and the ascending aorta ≤ 40 m
• Subject has a no atheromatous lesions int the arch and the BT, LCCA and LSA
• Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories
⁃ Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
⁃ Subject is affiliated with the social security system