Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Key facts
- Where
- Münich and Nuremberg, GermanySee the 2 sites
Where in Germany
- Department of Vascular Surgery, LMU Hospital MunichMünich, GermanyContact: Prof. Nikolaos TsilimparisTaking people
- Department of Vascular Surgery, Klinikum Nürnberg Campus SüdNuremberg, GermanyContact: Prof. Eric VerhoevenTaking people
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 doctorTrial details
- Who runs it
- Rede Optimus Hospitalar SA
- Trial code
- NCT06332911
- Record updated
- 23 May 2025
- Original description
Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.Read full original descriptionShow less
International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
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.
Inclusion: 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: 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.