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Intravascular Lithotripsy

Intravascular Lithotripsy for Peripheral Arterial Disease

N/A
Waitlist Available
Research Sponsored by Shockwave Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs
Age of subject is ≥ 18
Must not have
Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations
Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g., embolism)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to study the safety and effectiveness of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, similar procedures may include discomfort at the treatment site, bruising, bleeding, potential for artery damage or disruption of plaque that could block blood flow elsewhere.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have up to 2 lesions below the knee in my legs.
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I am 18 years old or older.
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I have up to 2 target lesions below the knee in my legs.
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My leg has severe blockage and pain from the knee to the ankle.
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My cancer lesion is 200 mm or smaller.
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I have good blood flow in at least one foot artery.
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My heart's blood vessels have moderate to severe calcium buildup.
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My leg has severe circulation problems, classified as Rutherford 3-5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My procedure to cross a blockage in my blood vessel with a guidewire was unsuccessful.
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I have untreated blockages in my leg arteries without serious complications.
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I have not had a stroke in the last 60 days.
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I have untreated significant leg artery blockages below the knee.
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I have a sudden loss of blood flow to my limb.
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I am currently in a research study for a new treatment or device.
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I am scheduled for a major leg amputation.
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My foot has poor blood circulation due to blocked arteries.
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My target lesion is in a natural or artificial vessel graft.
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My kidney function is very low, but I may be on dialysis.
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My target lesion is a narrowed area inside a stent.
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My treatment plan includes specific devices for my heart or artery procedure.
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My leg pain ranges from none to severe, affecting my ability to walk.
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I cannot take blood thinners due to my condition.
Select...
I have a severe infection in my foot that cannot be treated by removing toes or part of the foot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major Adverse Limb Events (MALE) + Post-Operative Death (POD)
Procedure Success
Secondary study objectives
Ankle-brachial index (ABI) or toe-brachial index (TBI)
Clinically Relevant Target Lesion Failure (CR-TLF)
Lesion Success
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-armExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Shockwave Medical, Inc.Lead Sponsor
31 Previous Clinical Trials
9,267 Total Patients Enrolled
10 Trials studying Peripheral Arterial Disease
2,041 Patients Enrolled for Peripheral Arterial Disease

Media Library

Peripheral Arterial Disease Clinical Trial 2023: Intravascular Lithotripsy Highlights & Side Effects. Trial Name: NCT05007925 — N/A
Intravascular Lithotripsy (Intravascular Lithotripsy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05007925 — N/A
~62 spots leftby Nov 2025
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