Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
NCT ID: NCT06332911
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2025-05-19
2027-05-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
Cracking-not-debulking technique (SHOCKWAVE IVL)
Interventions
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Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
Cracking-not-debulking technique (SHOCKWAVE IVL)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Rede Optimus Hospitalar SA
NETWORK
Responsible Party
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Principal Investigators
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Marc Bosiers, Dr.
Role: STUDY_DIRECTOR
Rede Optimus Hospitalar AG
Nikolaos Tsilimparis, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Vascular Surgery, LMU Hospital Munich
Locations
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Department of Vascular Surgery, LMU Hospital Munich
Münich, Bavaria, Germany
Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
Nuremberg, Bavaria, Germany
University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
Genoa, Liguria, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Veneto, Italy
Inselspital, University Hospital Bern, Heart Vascular Center
Bern, Canton Bern, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RO-231129
Identifier Type: -
Identifier Source: org_study_id
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