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Taking people in ItalyNo phase

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Key facts

Who runs it
Rede Optimus Hospitalar SA
Where
Genoa and Verona, ItalySee the 2 sitesAlso in 2 other countries, 3 sites
Trial code
Status
Recruiting
People taking part
30 people, planned
Started
19 May 2025
Expected to end
30 May 2027
Type of study
Observational
Treatments tested
  • Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
Record updated
23 May 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients submitted to surgical conduit bypass
  • Not-severely calcified disease (absence of calcification)
  • Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study
  • In-stent restenosis/occlusion
  • Inability to cross with 0.014 guidewire
  • Pre-stented iliac access vessels at the level of Shockwave implementation

Where in Italy

Also in 2 other countries, 3 sites

  • University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSMGenoa, ItalyContact: Prof. Giovanni PratesiTaking people
  • Azienda Ospedaliera Universitaria Integrata di VeronaVerona, ItalyContact: Prof. Gian Franco VeraldiTaking people

About the trial

What the trial wants to find out

Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.

Read full original descriptionShow less

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.

The group in the trial

  • complex endovascular thoracic aortic repair

    Patients submitted to complex endovascular thoracic aortic repair with hostile iliac access vessels using the Shockwave device to gain access.

    Treatment: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Record updated
23 May 2025