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RECRUITINGOBSERVATIONAL

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

No-profit, Pilot, Observational, Multicentric, Prospective Study on the Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access to Facilitate Aortic Endovascular Repair. SHOCK-ACCESS STUDY.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years old; - Patient (or their legal representative) understands the nature of the procedure and provides written willing to sign a consent form, 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (6)

Azienda Ospedaliero Universitaria delle Marche
Ancona, Ancona, Italy
Sant'Orsola Hospital
Bologna, Emilia-Romagna, Italy
Fondazione PTV - Policlinico Tor Vergata
Rome, Lazio, 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