Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

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.

Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure.

In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.

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 bypass.
2. Not-severely calcified disease (absence of calcification).
3. In-stent restenosis/occlusion.
4. Inability to cross with 0.014 guidewire.
5. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.
6. Pre-stented iliac access vessels at the level of Shockwave implementation.