Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair (TEVAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture; Abdominal Aortic Aneurysm Without Rupture; Thoracic Aortic Aneurysm Without Rupture
• Intervention / Treatment: Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Phina Muna, Dr.; Phone Number: +49 157 80 58 5869; Email: phina.muna@redeoptimus.com
• Study Contact Backup: Name: Annelena Held-Wehmöller, Dr.; Phone Number: +49 157 85128140; Email: annelena.held@redeoptimus.com

Study Locations

• Germany
  • Bavaria
    • Münich, Bavaria, Germany, 80337
      • Recruiting
      • Department of Vascular Surgery, LMU Hospital Munich
      • Contact: Prof. Nikolaos Tsilimparis; Phone Number: +49 (0)89 4400 73505; Email: Nikolaos.Tsilimparis@med.uni-muenchen.de
    • Nürnberg, Bavaria, Germany, 90471
      • Recruiting
      • Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
      • Contact: Prof. Eric Verhoeven; Phone Number: +49 (0) 911 398-2651; Email: eric.verhoeven@klinikum-nuernberg.de
• Italy
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Recruiting
      • University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
      • Contact: Prof. Giovanni Pratesi; Phone Number: +39 010 555 2424; Email: giovanni.pratesi@hsanmartino.it
  • Veneto
    • Verona, Veneto, Italy, 37126
      • Recruiting
      • Azienda Ospedaliera Universitaria Integrata di Verona
      • Contact: Prof. Gian Franco Veraldi; Phone Number: +39-045-812-2505; Email: gianfranco.veraldi@aovr.veneto.it
• Switzerland
  • Canton Bern
    • Bern, Canton Bern, Switzerland, CH-3010
      • Not yet recruiting
      • Inselspital, University Hospital Bern, Heart Vascular Center
      • Contact: Prof. Dr. Drosos Kotelis; Phone Number: +41(0)031 6325000; Email: drosos.kotelis@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient (m/f) age ≥ 18 years

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+; Cracking-not-debulking technique (SHOCKWAVE IVL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Technical success - defined as intention-to-treat basis	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	30 days

Collaborators and Investigators

• Sponsor: Rede Optimus Hospitalar SA
• Collaborators: Shockwave Medical, Inc.
• Investigators: Study Director: Marc Bosiers, Dr., Rede Optimus Hospitalar AG; Principal Investigator: Nikolaos Tsilimparis, Prof., Department of Vascular Surgery, LMU Hospital Munich

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Aortic Diseases; Aortic Aneurysm, Thoracoabdominal; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: RO-231129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No