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RECRUITING
NCT05145478

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

Sponsor: Yale University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2021-12-01

Completion Date

2027-06-01

Last Updated

2025-11-05

Healthy Volunteers

No

Interventions

DEVICE

Shockwave 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