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
Rede Optimus Hospitalar SA
30 participants
May 19, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria12
- 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).
- 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)
- We will accept the following presentations of aneurysm:
- urgent cases,
- elective,
- symptomatic
- and fast growing.
- 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 Criteria6
- Patients submitted to surgical conduit bypass.
- Not-severely calcified disease (absence of calcification).
- In-stent restenosis/occlusion.
- Inability to cross with 0.014 guidewire.
- Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study.
- Pre-stented iliac access vessels at the level of Shockwave implementation.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Cracking-not-debulking technique (SHOCKWAVE IVL)
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06332911