Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndoCore Lab s.r.l.
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
Sponsors and collaborators
EndoCore Lab s.r.l.
Lead sponsor
Fondazione Italiana Vascolare
Collaborator
Source ClinicalTrials.gov