Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patient (m/f) age ≥ 18 years at time of enrollment. 2. 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). 3. Hostile iliac access was defined in the presence of: * Heavily circumferential calcified iliac arteries * Inner diameter ≤ 6 mm * Severe stenosis (\> 50%; \> 2.5 m/s peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery) 4. We will accept the following presentations of aneurysm: * urgent cases, * elective, * symptomatic * and fast growing. 5. The repair was performed using Shockwave™ before the introduction of the main endograft. The iliac procedures can be accompanied by angioplasty and/or stent and stent-graft positioning. Exclusion Criteria: 1. Patients submitted to surgical conduit bypas