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
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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Aortic arch/Descending aorta Repair
CH de Brest
Brest, France
RECRUITINGHôpital Louis Pradel
Bron, France
NOT_YET_RECRUITINGCHU de Montpellier
Montpellier, France
RECRUITINGCH d'Orléans
Orléans, France
NOT_YET_RECRUITINGPrimary 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
Time frame: 30 days
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
Time frame: 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 1
Mean duration (min) of the procedure.
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 2
• Mean time (min) to implant
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 3
Proportion of subjects who underwent general anaesthesia.
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 4
Mean volume (cc) of estimated blood loss.
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 5
Proportion of subjects requiring blood transfusion
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 6
Mean length of time (days) of overall hospital stays
Time frame: 0 to 30 days
Intra/periprocedural through Discharge Clinical Utility Measures 7
Mean length of time (hours) in the intensive care unit.
Time frame: 0 to 30 days
Major adverse event
All-Cause Mortality * Myocardial Infarction * Paraplegia/Paraparesis * Renal Failure * Stroke/TIA * Left Arm/Hand Ischemia
Time frame: Up to 3 years
Secondary endovascular procedures
repeating procedures
Time frame: Up to 3 years
Secondary endovascular procedures for primary device failures
(including Type I/III endoleaks, aneurysm expansion, aneurysm/aortic rupture, and supra-aortic vessels including LSA stent-graft occlusion)
Time frame: Up to 3 years
Other
* Rupture * Endoleaks * Maximum aneurysm diameter changes from baseline\* * Exclusion of aneurysm * Exclusion of penetrating aortic ulcer (PAU) * Stent graft patency * Stent graft integrity * Conversion to surgical repair * Surgical revascularisation of the LSA, LCCA, BT * Paraparesis * Adverse events including serious adverse events and device, procedure, and/or disease-related adverse events
Time frame: Up to 3 years
For TBAD, these additional observations will be evaluated
Coverage of primary entry tear (exclusion of false lumen) * Extension of dissection (proximally or distally) with or without complications * Continuing or new false lumen (FL) perfusion * Aortic remodeling post-procedure
Time frame: 0 to 30 days
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