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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Department of Vascular Surgery, LMU Hospital Munich
RECRUITING
Münich
Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
RECRUITING
Nuremberg
Italy
University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
RECRUITING
Genoa
Azienda Ospedaliera Universitaria Integrata di Verona
RECRUITING
Verona
Switzerland
Inselspital, University Hospital Bern, Heart Vascular Center
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Phina Muna, Dr.
phina.muna@redeoptimus.com
+49 157 80 58 5869
Backup
Annelena Held-Wehmöller, Dr.
annelena.held@redeoptimus.com
+49 157 85128140
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Collaborators: Shockwave Medical, Inc.
Leads: Rede Optimus Hospitalar SA

This content was sourced from clinicaltrials.gov