Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06332911

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Vascular Surgery, LMU Hospital Munich, Münich, Bavaria, Germany

Loading trial locations.

About this study

Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure.

In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Device

Cracking-not-debulking technique (SHOCKWAVE IVL)

Primary outcomes

  1. Efficacy: Technical success - defined as intention-to-treat basis

    Time frame: 30 days

    • Successful dilatation of the access vessels to 8mm without rupture
    • Successful endovascular access and deployment of all aortic devices
    • Performance of the Shockwave™ IVL: Includes the definition for technical success as well as delivery of the intended main endograft without the need for surgical conversion, arterial rupture and iliac artery occlusion

Study contacts

Contact information is provided by the study sponsor or research team.

Annelena Held-Wehmöller, Dr.

CONTACT

[email protected]

+49 157 85128140

Phina Muna, Dr.

CONTACT

[email protected]

+49 157 80 58 5869

Sponsors and collaborators

Lead sponsor

Rede Optimus Hospitalar SA

Network

Collaborators

  • Shockwave Medical, Inc.

Registry information

Official study title

International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Acronym: TEVAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2024
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.