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Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Recruitingn/aAges 18 Years - anyAllRede Optimus Hospitalar SA
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
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Where

5 sites
Department of Vascular Surgery, LMU Hospital Munich
Münich, Germany
Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
Nuremberg, Germany
University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
Genoa, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy
Inselspital, University Hospital Bern, Heart Vascular Center
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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