Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies

Prospective, single-arm, non-randomised, multicenter, investigator initiated clinical study evaluating subjects implanted with The Valiant Captivia physician fenestrated stent graft for the treatment of aneurysms/penetrating ulcers, Type B aortic dissections or residual dissection after Type A repair, of the aortic arch and the descending thoracic aorta which are candidates for revascularisation of all three supra-aortic vessels (BT (brachiocephalic trunk) , LCCA (left Common Carotid artery), LSA (Left Subclavian Artery)

Inclusion criteria

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

Inclusion criteria

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

Exclusion criteria

(Thoracic Aortic Aneurysms and Penetrating Ulcers, TAA/PAU):

• Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
• Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
• Subject has an aneurysmal, tortuous, or atherosclerotic BT.
• Subject has an ascending aorta diameter > 40 mm
• Subject has thrombus in the proximal neck
• Subject has an emergent need of treatment of the aortic pathology
• Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites
• Subject has circumferential calcification in the common femoral or external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
• Subject has an aortic atheroma classified as grade IV or grade V.
• Subject has had previous endovascular repair of the ascending
• Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise sealing of the device.
• Subject is pregnant
• Subject has a known allergy or intolerance to the device components.
• Subject is in acute renal failure
• Subject has a body habitus which prevents adequate visualisation of the aorta.
• Subject has coronary artery disease with unstable angina and who has not received treatment.
• Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
• Subject has active systemic infection and/or a mycotic aneurysm.
• Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
• Subject has a life expectancy of less than 2 years year.
• Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
• Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
• Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
• Subject has had a cerebral vascular accident (CVA) within 3 months.
• Subject has had a myocardial infarction (MI) within 3 months.
• Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Exclusion criteria

(Type B Dissections, TBAD and residual dissection after Type A repair):

• Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
• Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
• Subject has an aneurysmal, tortuous, or atherosclerotic BT.
• Subject has a dissected BT and or LCCA
• Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites.
• Subject has circumferential calcification in the common femoral artery, external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
• Subject has an aortic atheroma classified as grade IV or grade V.
• Subject has had previous endovascular repair of the ascending, arch
• Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal sealing sites that would compromise seal of the device
• Subject is pregnant
• Subject has a known allergy or intolerance to the device components
• Subject is in acute renal failure
• Subject has a body habitus which prevents adequate visualisation of the aorta.
• Subject has coronary artery disease with unstable angina and who has not received treatment.
• Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
• Subject has active systemic infection and/or a mycotic aneurysm.
• Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observationsof this study
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
• Subject has a life expectancy of less than 2 years.
• Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
• Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
• Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
• Subject has had a cerebral vascular accident (CVA) within 3 months.
• Subject has had a myocardial infarction (MI) within 3 months.
• Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

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