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Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries

NCT05284240•Midwest Cardiovascular Research Foundation

Summary

The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis

Detailed Description

To observe the treatment effects of the Auryon Laser Atherectomy System in treating Infrapopliteal peripheral arterial disease

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1\. Subject is 18 years of age or older. 2. Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
•1. Target lesions(s) must be viewed angiographically and have ≥50% stenosis. More than one lesion can be included in the same vessel.
•2. Only 1 target vessel is included in the study.
•3. Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion.
•Target Lesion reference vessel diameter (RVD) between 1.5 mm - 4.5 mm. by investigator estimate.
•4\. Target lesion is denovo or restenotic.
•\-

Exclusion Criteria

•1. Target lesion is in a vessel graft or synthetic graft.
•2. Subjects requiring dialysis.
•3. Subject is unable to understand the study or has a history of non-compliance with medical advice.
•4. Subject is unwilling or unable to sign the Informed Consent Form (ICF)
•5. Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints.
•6. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
•7. Subject has a CVA or TIA within 4 weeks prior to the Auryon procedure.
•8. Planned Use of another debulking device or specialty balloons before or after the Auryon laser during the index procedure
•9. Patient has any planned surgical intervention or endovascular procedure ≤14 days after the index procedure or had these procedures in the past 14 days
•10. Life expectancy of less than one year judged by the investigator
+14 more criteria

Locations (2)

Palm Vascular Centers

Miami Beach, Florida, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Key Dates

Start Date

March 17, 2022

Primary Completion Date

September 25, 2024

Completion Date

September 25, 2024

Last Updated

November 21, 2024

Enrollment

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

Auryon Laser System

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

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