Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.
The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.
Patient (m/f) age ≥ 18 years at time of enrollment.
Diagnosis of thoracic and/or thoraco-abdominal (Extent I-V) and juxta/para-renal/short-neck aneurysm requiring the implantation of a thoracic and/or thoraco-abdominal fenestrated/branched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 Fr (6 mm).
Heavily circumferential calcified iliac arteries
Inner diameter ≤ 6 mm
Patients submitted to surgical conduit bypass.
Not-severely calcified disease (absence of calcification).
In-stent restenosis/occlusion.
Inability to cross with 0.014 guidewire.
Rede Optimus Hospitalar SA
Lead sponsor
Shockwave Medical, Inc.
Collaborator