Using Shockwave technology to treat calcified iliac access for aortic procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the efficacy and safety of the Shockwave™ M5+ Peripheral Intravascular Lithotripsy Catheter in facilitating the delivery of large-bore aortic devices through severely calcified iliac access. Eligible patients will be enrolled after providing informed consent, and their medical history, treatment details, and outcomes will be monitored for up to 12 months post-procedure. The study aims to gather data on the medical care received during the procedure without introducing additional tests or interventions. Follow-up visits will occur at 30 days, 6 months, and 12 months after discharge.

Why it matters

Who can join: the full rules

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.

Where it's running

• Azienda Ospedaliero Universitaria delle Marche
  Ancona, Ancona, Italy Recruiting
• Fondazione PTV - Policlinico Tor Vergata
  Rome, Lazio, Italy Recruiting
• Sant'Orsola Hospital
  Bologna, Emilia-Romagna, Italy Not yet recruiting
• Ospedale San Giovanni di Dio
  Florence, Tuscany, Italy Not yet recruiting
• Ospedale Santa Maria della Misericordia di Perugia
  Perugia, Umbria, Italy Not yet recruiting
• Azienda Ospedaliero-Universitaria di Padova
  Padova, Veneto, Italy Not yet recruiting

Study contacts

• Principal investigator: Stefano Fazzini, MD — Fondazione PTV - Policlinico Tor Vergata
• Study coordinator: Daniela Ramaccini, PhD, PharmD
• Email: d.ramaccini@endocorelab.org
• Phone: +39 3534390426

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.