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

Recruiting now

Conditions studied: Aortic Diseases, Aorto-Iliac Atherosclerosis, Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT05880641

Run by

EndoCore Lab s.r.l.

People needed

40

Starts

2023-06-26

Expected to finish

2027-09-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Azienda Ospedaliero Universitaria delle Marche — Ancona, Ancona, Italy (enrolling)
• Fondazione PTV - Policlinico Tor Vergata — Rome, Lazio, Italy (enrolling)
• Sant'Orsola Hospital — Bologna, Emilia-Romagna, Italy
• Ospedale San Giovanni di Dio — Florence, Tuscany, Italy
• Ospedale Santa Maria della Misericordia di Perugia — Perugia, Umbria, Italy
• Azienda Ospedaliero-Universitaria di Padova — Padova, Veneto, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.