Clinical trial NCT06332911: Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Official title: International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
Abdominal Aortic Aneurysm Without Rupture
Thoracic Aortic Aneurysm Without Rupture
Lead sponsor: Rede Optimus Hospitalar SA
Sponsor class: NETWORK
Collaborators: name: Shockwave Medical, Inc.
First posted: 2024-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient (m/f) age ≥ 18 years

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy: Technical success - defined as intention-to-treat basis
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Münich
country: Germany
facility: Department of Vascular Surgery, LMU Hospital Munich
state: Bavaria
city: Nürnberg
country: Germany
facility: Department of Vascular Surgery, Klinikum Nürnberg Campus Süd
state: Bavaria
city: Genova
country: Italy
facility: University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
state: Liguria
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
state: Veneto
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern, Heart Vascular Center
state: Canton Bern
Study officials:
affiliation: Rede Optimus Hospitalar AG
name: Marc Bosiers, Dr.
role: STUDY_DIRECTOR
affiliation: Department of Vascular Surgery, LMU Hospital Munich
name: Nikolaos Tsilimparis, Prof.
role: PRINCIPAL_INVESTIGATOR
References: