RecruitingNCT05145478

CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions


Sponsor

Yale University

Enrollment

50 participants

Start Date

Dec 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (CRUSH PAD) is collecting real-world information about how Shockwave Intravascular Lithotripsy (IVL) — a technique that uses sound waves to break up calcium buildup inside leg arteries — works in patients with calcified blockages in the common femoral artery (the large artery at the top of the thigh). It is not a randomized trial but rather an observational study to understand real-world outcomes. You may be eligible if: - You are 18 years of age or older - You have leg pain when walking or rest pain, or wounds on your legs (Rutherford categories 2–6) due to artery disease - You are scheduled to receive Shockwave IVL treatment for a calcified blockage in your common femoral artery - You speak English or Spanish You may NOT be eligible if: - You are a prisoner - You are pregnant or nursing - You have cognitive impairment documented in your medical records - You have a life expectancy of less than 12 months - You have had a prior endarterectomy (surgical opening) of the common femoral artery - You are enrolled in another interventional study Talk to your doctor to see if this trial is right for you.

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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Interventions

DEVICEShockwave Intravascular Lithotripsy (IVL)

Eligible patients with atherosclerotic lesions in the femoral artery who either have claudication or critical limb ischemia will receive endovascular treatment in addition to be treated with Shockwave Intravascular Lithotripsy (IVL) technology.


Locations(2)

Yale New Haven Health

New Haven, Connecticut, United States

The Miriam Hospital

Providence, Rhode Island, United States

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NCT05145478


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