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.
Patient (m/f) age ≥ 18 years
Other
Prospective
Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
DeviceCracking-not-debulking technique (SHOCKWAVE IVL)
Efficacy: Technical success - defined as intention-to-treat basis
* Successful dilatation of the access vessels to 8mm without rupture * Successful endovascular access and deployment of all aortic devices * Performance of the Shockwave™ IVL: Includes the definition for technical success as well as delivery of the intended main endograft without the need for surgical conversion, arterial rupture and iliac artery occlusion
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Rede Optimus Hospitalar SA
Lead sponsor
Shockwave Medical, Inc.
Collaborator
