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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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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.

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

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

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
28 Previous Clinical Trials
7,916 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
~0 spots leftby Jun 2024
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