Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

NCT06332911 | Recruiting

• 1 other identifier: RO-231129
• Study Type: observational
• Target: 30
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture; Abdominal Aortic Aneurysm Without Rupture; Thoracic Aortic Aneurysm Without Rupture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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+

Interventions

Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+ DEVICE

Cracking-not-debulking technique (SHOCKWAVE IVL)

complex endovascular thoracic aortic repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient (m/f) age ≥ 18 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rede Optimus Hospitalar SA: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (5)

Department of Vascular Surgery, LMU Hospital Munich

Münich, Bavaria, 80337, Germany

RECRUITING

Department of Vascular Surgery, Klinikum Nürnberg Campus Süd

Nuremberg, Bavaria, 90471, Germany

RECRUITING

University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM

Genoa, Liguria, 16132, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Veneto, 37126, Italy

RECRUITING

Inselspital, University Hospital Bern, Heart Vascular Center

Bern, Canton Bern, CH-3010, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Marc Bosiers, Dr.

  Rede Optimus Hospitalar AG

  STUDY DIRECTOR

• Nikolaos Tsilimparis, Prof.

  Department of Vascular Surgery, LMU Hospital Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phina Muna, Dr.

CONTACT

+49 157 80 58 5869; phina.muna@redeoptimus.com

Annelena Held-Wehmöller, Dr.

CONTACT

+49 157 85128140; annelena.held@redeoptimus.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); CH (1); DE (2)