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.
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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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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