Intravascular Lithotripsy for Peripheral Arterial Disease

Recruiting in Palo Alto (17 mi)

+45 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Shockwave Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.

Eligibility Criteria

Adults over 18 with Peripheral Arterial Disease affecting the legs, specifically below-the-knee arteries. Participants must have a life expectancy over a year and be able to follow study procedures. They should have moderate to severe artery calcification or non-dilatable lesions, and not be allergic to certain materials like urethane or silicone.

Inclusion Criteria

Subject is able and willing to comply with all assessments in the study

I have up to 2 lesions below the knee in my legs.

The size of the blood vessels near the affected area should be between 2.0 mm and 4.0 mm as determined by the doctor.

+12 more

Exclusion Criteria

A procedure done to open a blocked artery didn't work and caused serious complications that can be seen on X-ray images.

My procedure to cross a blockage in my blood vessel with a guidewire was unsuccessful.

I have untreated blockages in my leg arteries without serious complications.

+24 more

Participant Groups

The trial is testing the Shockwave Medical Peripheral IVL System's safety and effectiveness in treating calcified, narrowed arteries below the knee. It's an observational study where all participants receive Intravascular Lithotripsy (IVL) without being compared to another group.

1Treatment groups

Experimental Treatment

Group I: Single-armExperimental Treatment1 Intervention