RecruitingNCT05880641

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.


Sponsor

EndoCore Lab s.r.l.

Enrollment

40 participants

Start Date

Jun 26, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the Shockwave IVL (Intravascular Lithotripsy) catheter as a tool to prepare severely calcified or narrowed iliac arteries (the large vessels in the pelvis) for endovascular aortic repair. When patients need a stent graft placed in their aorta, the graft delivery system must pass through the iliac arteries — but heavy calcium buildup can make this impossible or dangerous. IVL uses pulsed sound energy to crack the calcium inside the artery wall, making it flexible enough to accommodate the graft. Eligible patients must be 18 or older with aortic disease requiring endovascular treatment but facing severely calcified iliac arteries that make standard delivery unfeasible. Specific calcium grade (3 or 4 on a coronary classification scale) and lesion length criteria must be met. People with bilateral iliac occlusion, acute limb ischemia with thrombus, hemodynamic instability, or life expectancy under 12 months are excluded. Participants undergo IVL pretreatment followed by the planned aortic stent graft procedure, with imaging and clinical follow-up visits. This research matters because it expands the range of patients who can safely benefit from minimally invasive aortic repair, avoiding the higher risks associated with open surgery in patients who are already medically complex.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT05880641


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