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Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access

Recruitingn/aAges 18 Years - anyAllEndoCore Lab s.r.l.
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In plain words

What the trial is, and whether it could suit you

The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

6 sites
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Sant'Orsola Hospital
Bologna, Italy
Fondazione PTV - Policlinico Tor Vergata
Rome, Italy
Ospedale San Giovanni di Dio
Florence, Italy
Ospedale Santa Maria della Misericordia di Perugia
Perugia, Italy
Azienda Ospedaliero-Universitaria di Padova
Padova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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