Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Recruiting now

Conditions studied: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture

In brief

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.

Key facts

Study ID

NCT06332911

Run by

Rede Optimus Hospitalar SA

People needed

30

Starts

2025-05-19

Expected to finish

2027-05-30

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Vascular Surgery, LMU Hospital Munich — Münich, Bavaria, Germany (enrolling)
• Department of Vascular Surgery, Klinikum Nürnberg Campus Süd — Nuremberg, Bavaria, Germany (enrolling)
• University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM — Genoa, Liguria, Italy (enrolling)
• Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Veneto, Italy (enrolling)
• Inselspital, University Hospital Bern, Heart Vascular Center — Bern, Canton Bern, Switzerland

Full record on ClinicalTrials.gov

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