Using Shockwave technology for aortic repair procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon in treating challenging iliac access during thoracic and thoraco-abdominal aortic repairs. It involves collecting standardized data on procedures, underlying conditions, and cardiovascular risks, along with physiological parameters measured before, during, and after surgery. Follow-up visits at 1 month, 6 months, and 12 months will assess adverse events and the success of the procedures. The study aims to analyze the technical success of accessing hostile iliac vessels using this innovative technology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient (m/f) age ≥ 18 years at time of enrollment.
2. 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).
3. 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)
4. We will accept the following presentations of aneurysm:

   * urgent cases,
   * elective,
   * symptomatic
   * and fast growing.
5. 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 Criteria:

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

Where it's running

• Department of Vascular Surgery, LMU Hospital Munich
  Münich, Bavaria, Germany Recruiting
• Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
  Nuremberg, Bavaria, Germany Recruiting
• University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
  Genoa, Liguria, Italy Recruiting
• Azienda Ospedaliera Universitaria Integrata di Verona
  Verona, Veneto, Italy Recruiting
• Inselspital, University Hospital Bern, Heart Vascular Center
  Bern, Canton Bern, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Nikolaos Tsilimparis, Prof. — Department of Vascular Surgery, LMU Hospital Munich
• Study coordinator: Phina Muna, Dr.
• Email: phina.muna@redeoptimus.com
• Phone: +49 157 80 58 5869

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.