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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

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

0 / 8Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals are researchers striving to achieve with this clinical experiment?

"This medical trial is principally looking to monitor Major Adverse Limb Events (MALE) + Post-Operative Death (POD), as well as secondary objectives such as Serious angiographic complications, Clinically Relevant Target Lesion Failure (CR-TLF), and Primary Patency. The latter metric being the absence of total occlusion in target lesions at 6 and 12 months post operation, supplemented by a clinically driven revascularization if needed."

Answered by AI

How manifold locations are carrying out this clinical experiment?

"This trial is welcoming patients at Stanford Hospital in Palo Alto, California, North carolina Heart & Vascular in Raleigh and Pinnacle Health Cardiovascular Institute in Harrisburg. Other 40 sites are also available for recruitment purposes."

Answered by AI

Is enrollment for this research project available to the public?

"As per the information hosted on clinicaltrials.gov, this study has stopped recruiting participants as of July 26th 2022; though initially posted to the website on November 18 2021. Fortunately, there are 216 other trials that are still looking for patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

2021. "Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05007925.

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