Abdominal Aortic Aneurysm Without Rupture, Thoracic Aortic Aneurysm Without Rupture, Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
Conditions
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.
Interventions
DEVICEShockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
Cracking-not-debulking technique (SHOCKWAVE IVL)
Sponsors
Shockwave Medical, Inc.
Rede Optimus Hospitalar SA
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Technical success - defined as intention-to-treat basis | 30 days | * 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 |
Countries
Germany, Italy, Switzerland
Contacts
Primary ContactPhina Muna, Dr.
Backup ContactAnnelena Held-Wehmöller, Dr.
Outcome results
None listed