Shockwave therapy opens hardened arteries for Life-Saving aortic repair
NCT ID NCT05880641
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special balloon that uses shockwaves to crack calcium buildup in the iliac arteries, making it possible to deliver large aortic stents. About 40 adults with severe aortic disease and hardened arteries will be enrolled. The goal is to see if this approach is safe and effective for enabling endovascular repair.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with aortic diseases (abdominal, thoracic or thoraco-abdominal, aneurysms, dissections, PAU, IMH) with hostile iliac access (calcified and narrowed) associated or not to aorto-iliac occlusive disease (AIOD).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years old; * Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study; * Patient presenting with aortic disease indicated for endovascular treatment considered unfeasible based on severely calcified iliac access and outer diameter of the "ideal" aortic endograft at onset of the procedure (considering the main body and/or contralateral limb in case of iliac distal landing zone); * Patients presenting a ratio \> 0.2 between outer diameter of the aortic stent graft delivery system (OD-SG) and minimum lumen diameter (MLD); decision concerning SG will be taken balancing the lower profile on the market and the better graft fit for patient's anatomy; * Patients presenting calcium grade 3 or 4 accordingly to 360° coronary classification (grade 1 = 0-90°, grade 2 = 90°-180°; grade 3 = 180°-270°; grade 4 = 270°-360°); * Patients presenting a lesion length \> 20 mm, intended as the sum of all calcified iliac lesions between two endpoints, from the aortic bifurcation up to the proximal common femoral artery (CFA); * Patients eligible for treatment with Shockwave M5+ IVL device; * Patients presenting with aortic disease indicated for endovascular treatment associated or not to aorto-iliac occlusive disease (Rutherford classification score II - VI for chronic limb ischemia); * Patients compliant with the conduct of follow-up visits according to the timelines specified in the protocol. Exclusion Criteria: * Bilateral Iliac Occlusion; * Urgent setting with presence of iliac thrombus (acute limb ischemia); * Any patient considered to be hemodynamically unstable at procedure onset; * Patients refusing treatment; * Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated; * Patients with a history of prior life-threatening contrast medium reaction; * Life expectancy of less than twelve months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliero Universitaria delle Marche
RECRUITINGAncona, Ancona, 60126, Italy
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Azienda Ospedaliero-Universitaria di Padova
NOT_YET_RECRUITINGPadova, Veneto, 35128, Italy
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Fondazione PTV - Policlinico Tor Vergata
RECRUITINGRome, Lazio, 00133, Italy
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Ospedale San Giovanni di Dio
NOT_YET_RECRUITINGFlorence, Tuscany, 50143, Italy
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Ospedale Santa Maria della Misericordia di Perugia
NOT_YET_RECRUITINGPerugia, Umbria, 06156, Italy
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Sant'Orsola Hospital
NOT_YET_RECRUITINGBologna, Emilia-Romagna, 40138, Italy
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