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Recruiting NCT06332911

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

— Observational Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture Abdominal Aortic Aneurysm Without Rupture Thoracic Aortic Aneurysm Without Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+.
Who it may be relevant to
Registry conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Italy, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Overview

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.

Detailed description

Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure.

In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.

Interventions

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

Primary outcome measures

  • Efficacy: Technical success - defined as intention-to-treat basis [Time frame: 30 days]

Eligibility criteria

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:
  • 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 2 centers
  • Department of Vascular Surgery, LMU Hospital Munich — Münich
  • Department of Vascular Surgery, Klinikum Nürnberg Campus Süd — Nuremberg
Italy · 2 centers
  • University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM — Genoa
  • Azienda Ospedaliera Universitaria Integrata di Verona — Verona
Switzerland · 1 center
  • Inselspital, University Hospital Bern, Heart Vascular Center — Bern

Identifiers

NCT: NCT06332911 · RO-231129

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗