Actively Recruiting
Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Led by Rede Optimus Hospitalar SA · Updated on 2025-05-23
30
Participants Needed
5
Research Sites
105 weeks
Total Duration
On this page
Sponsors
R
Rede Optimus Hospitalar SA
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 years or older at enrollment
- Diagnosed with thoracic and/or thoraco-abdominal (Extent I-V) or juxta/para-renal/short-neck aneurysm needing thoracic or thoraco-abdominal fenestrated/branched aortic endograft with delivery sheath diameter 6 18 Fr (6 mm)
- Presence of hostile iliac access defined by heavily calcified iliac arteries, inner diameter 6 6 mm, or severe stenosis (>50%, >2.5 m/s peak velocity, absence of triphasic duplex signal in ipsilateral common femoral artery)
- Cases can be urgent, elective, symptomatic, or fast growing aneurysms
- Use of Shockwave™ before main endograft introduction; iliac procedures may include angioplasty and/or stent or stent-graft placement
You will not qualify if you...
- Patients who have had surgical conduit bypass
- Patients without severe calcification in iliac arteries
- Presence of in-stent restenosis or occlusion
- Inability to cross iliac artery with a 0.014 guidewire
- Any significant medical condition that may affect optimal study participation, as judged by the investigator
- Previously pre-stented iliac access vessels at Shockwave implementation level
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Department of Vascular Surgery, LMU Hospital Munich
Münich, Bavaria, Germany, 80337
Actively Recruiting
2
Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
Nuremberg, Bavaria, Germany, 90471
Actively Recruiting
3
University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
Genoa, Liguria, Italy, 16132
Actively Recruiting
4
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Veneto, Italy, 37126
Actively Recruiting
5
Inselspital, University Hospital Bern, Heart Vascular Center
Bern, Canton Bern, Switzerland, CH-3010
Not Yet Recruiting
Research Team
P
Phina Muna, Dr.
CONTACT
A
Annelena Held-Wehmöller, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here