Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Recruiting
Observational Study
Thoracoabdominal Aortic Aneurysm, Without Mention of RuptureAbdominal Aortic Aneurysm Without RuptureThoracic Aortic Aneurysm Without Rupture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
Rede Optimus Hospitalar SA · Research network
Who this trial is looking for
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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.
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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 sy…
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.
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