About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

6
Azienda Ospedaliero Universitaria delle Marche60126, AnconaAncona, Italy
Sant'Orsola Hospital40138, BolognaEmilia-Romagna, Italy
Fondazione PTV - Policlinico Tor Vergata00133, RomeLazio, Italy
Ospedale San Giovanni di Dio50143, FlorenceTuscany, Italy

Sponsors and collaborators

EndoCore Lab s.r.l.

Lead sponsor

Fondazione Italiana Vascolare

Collaborator