Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and De… (NCT05479305) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
France30 participantsStarted 2023-11-21
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.