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
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 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
Single group
The Valiant Captivia Stent Graft
DeviceAortic arch/Descending aorta Repair
Primary Safety Endpoints:
Within one month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta-Related Mortality * Stroke/TIA (Transient Ischemic Attack) * Paraplegia/paraparesis * Left Arm/Hand Ischemia
Primary Effectiveness Endpoints:
The primary effectiveness endpoint is treatment success (defined below) and will be captured within the initial reporting period of 1 month from the index procedure. Treatment success defined as technical success comprising the following: * the successful delivery and deployment of the stent graft (The Valiant Captivia physician fenestrated Stent Graft) at the planned location * no unintentional coverage of supra-aortic vessels, assessed intra-operatively, * the removal of the delivery system * successful exclusion of the aortic lesion while maintaining patency of the LSA stent-graft as well as LCCA and BT at the 30-day visit
Intra/periprocedural through Discharge Clinical Utility Measures 1
Mean duration (min) of the procedure.
Intra/periprocedural through Discharge Clinical Utility Measures 2
• Mean time (min) to implant
Intra/periprocedural through Discharge Clinical Utility Measures 3
Proportion of subjects who underwent general anaesthesia.
Intra/periprocedural through Discharge Clinical Utility Measures 4
Mean volume (cc) of estimated blood loss.
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Ceric Sàrl
Lead sponsor
European Cardiovascular Research Center
Collaborator
