RecruitingNot Applicable

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Germany, Italy, Switzerland30 participantsStarted 2025-05-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. We will accept the following presentations of aneurysm:
✓. 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

✕. 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.

What they're measuring

Efficacy: Technical success - defined as intention-to-treat basis

Timeframe: 30 days

Trial details

NCT IDNCT06332911

SponsorRede Optimus Hospitalar SA

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-05-30

Contact for this trial

Phina Muna, Dr.

+49 157 80 58 5869 phina.muna@redeoptimus.com

View on ClinicalTrials.gov More Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture trials