Ireland
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Recruiting Observational

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

NCT06332911 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-05-19
Last updated
2025-05-23

Condition(s) studied

Thoracoabdominal Aortic Aneurysm, Without Mention of RuptureAbdominal Aortic Aneurysm Without RuptureThoracic Aortic Aneurysm Without Rupture

Investigational drug(s) / intervention(s)

Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+: Cracking-not-debulking technique (SHOCKWAVE IVL)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Efficacy: Technical success - defined as intention-to-treat basis — 30 days
    * Successful dilatation of the access vessels to 8mm without rupture * Successful endovascular access and deployment of all aortic devices * Performance of the Shockwave™ IVL: Includes the definition for technical success as well as delivery of the intended main endograft without the need for surgical conversion, arterial rupture and iliac artery occlusion

Trial sites (5)

FacilityCityRegionStatus
Department of Vascular Surgery, LMU Hospital Munich Münich Bavaria Recruiting
Department of Vascular Surgery, Klinikum Nürnberg Campus Süd Nuremberg Bavaria Recruiting
University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM Genoa Liguria Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona Verona Veneto Recruiting
Inselspital, University Hospital Bern, Heart Vascular Center Bern Canton Bern Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06332911 on ClinicalTrials.gov ↗ ← All trials in Italy