Using Shockwave technology to treat calcified iliac access for aortic procedures

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.

This study is testing if a special shockwave device can help doctors safely deliver large aortic devices through patients' blocked iliac arteries.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: EndoCore Lab s.r.l. (Academic / other)
• Locations: 6 sites (Ancona, Ancona and 5 other locations)
• Trial ID: NCT05880641 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with aortic disease and severely calcified iliac access deemed unfeasible for standard endovascular treatment.

Not a fit: Patients without significant calcification or those not requiring endovascular treatment for aortic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve access for patients with severe calcification, leading to better treatment outcomes for aortic diseases.

How similar studies have performed: While this approach is innovative, similar studies using intravascular lithotripsy have shown promise in treating calcified vascular lesions.

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.

Where this trial is running

Ancona, Ancona and 5 other locations

• Azienda Ospedaliero Universitaria delle Marche — Ancona, Ancona, Italy (Recruiting)
• Sant'Orsola Hospital — Bologna, Emilia-Romagna, Italy (Not_yet_recruiting)
• Fondazione PTV - Policlinico Tor Vergata — Rome, Lazio, Italy (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

Conditions Aortic Diseases; Aorto-Iliac Atherosclerosis; Peripheral Arterial Disease; Aortic Disease; Intravascular Lithotripsy; Hostile Access