RecruitingNCT06332911

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


Sponsor

Rede Optimus Hospitalar SA

Enrollment

30 participants

Start Date

May 19, 2025

Study Type

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

Min Age: 18 Years

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.

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Interventions

DEVICEShockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Cracking-not-debulking technique (SHOCKWAVE IVL)


Locations(5)

Department of Vascular Surgery, LMU Hospital Munich

Münich, Bavaria, Germany

Department of Vascular Surgery, Klinikum Nürnberg Campus Süd

Nuremberg, Bavaria, Germany

University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM

Genoa, Liguria, Italy

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Veneto, Italy

Inselspital, University Hospital Bern, Heart Vascular Center

Bern, Canton Bern, Switzerland

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NCT06332911


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