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Shockwave balloon for narrow, hard-to-pass leg arteries during aortic aneurysm repair

Observes a shockwave balloon used in people having aortic aneurysm repair with difficult artery access.

Key facts

Who runs it
Rede Optimus Hospitalar SA
Where
Bern, SwitzerlandSee the siteAlso in 2 other countries, 4 sites
Trial code
Registry title
Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
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

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with an aneurysm (a bulge) of the aorta in the chest and/or belly. They need a stent-graft repair through the groin, and their pelvic arteries are hard to pass. The Shockwave™ balloon is used to open these arteries.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Thoracic and/or thoraco-abdominal (Extent I-V) or juxta/para-renal/short-neck aneurysm. It needs a fenestrated/branched aortic endograft with a delivery sheath of 18 Fr (6 mm) or larger. Urgent, elective, symptomatic and fast-growing aneurysms can join.
Earlier treatment
The Shockwave™ balloon was used on the pelvic arteries before the main endograft was placed. Angioplasty, stents or stent-grafts may also be used there.
Biomarker or test result
Hostile iliac access: heavily calcified pelvic arteries, inner diameter ≤ 6 mm, or severe narrowing (> 50%; > 2.5 m/s peak velocity; no triphasic duplex signal in the common femoral artery on the same side).

Main reasons for not taking part

  • Surgical conduit bypass was done
  • Little or no calcium in the arteries
  • Re-narrowing or blockage inside an existing stent, or a stent already in the artery where Shockwave would be used
  • The 0.014 guidewire cannot pass the narrowing
  • Another serious medical condition that the doctor thinks would get in the way of taking 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 Switzerland

Also in 2 other countries, 4 sites

  • Inselspital, University Hospital Bern, Heart Vascular CenterBern, SwitzerlandContact: Prof. Dr. Drosos KotelisNot yet recruiting

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

Print a page for my doctor

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
Plain-language title
Shockwave balloon for narrow, hard-to-pass leg arteries during aortic aneurysm repairGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
23 May 2025