Intravascular Lithotripsy for Peripheral Arterial Disease

Recruiting at 45 trial locations

Overseen By Jennifer Sullivan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shockwave Medical, Inc.

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Stroke, Renal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: At procedure

250 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Shockwave Medical Peripheral IVL System for treatment of calcified, stenotic BTK arteries

At procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 30 days, 6, 12, and 24 months

Treatment Details

Interventions

• Intravascular Lithotripsy

Trial Overview 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.

Participant Groups

Group I: Single-arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Shockwave Medical, Inc.

Lead Sponsor

Trials

38

Recruited

10,200+