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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
Full description
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)
Enrollment
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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:
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:
Exclusion criteria
(Thoracic Aortic Aneurysms and Penetrating Ulcers, TAA/PAU):
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.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Laure Morsiani, PhD
Data sourced from clinicaltrials.gov
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