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

Launched by ENDOCORE LAB S.R.L. · May 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called intravascular lithotripsy using the Shockwave™ M5+ catheter to help people with aortic diseases, particularly those who have calcified iliac arteries that make it difficult to receive standard treatment. The goal is to see if this technique can safely and effectively allow doctors to use larger devices needed for treating these conditions. The trial is currently looking for participants, and it is open to adults aged 18 and older, who have severely calcified arteries and specific measurements indicating they qualify for this treatment.

If you or a loved one takes part in this trial, you can expect to undergo a procedure that uses sound waves to break up the calcium buildup in the arteries, which may help the doctors insert necessary devices more easily. Participants will need to provide informed consent, meaning they understand the procedure and its purpose. They will also have follow-up visits to monitor their progress. However, not everyone can join; for example, individuals with certain artery blockages, unstable health conditions, or specific medication restrictions may not be eligible. This study aims to improve treatment options for those facing challenges due to calcified arteries.

Gender

ALL

Eligibility criteria

• 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.