Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone

NCT06777901 | Recruiting Phase 4 FDA Device

• 1 other identifier: 2024-RFT-A-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.

Conditions

Peripheral Arterial Diseases

Outcome Measures

Primary Outcomes (1)

• Win-ratio comparing subjects in the treatment group versus the control group on the components of the composite endpoints in a hierarchical fashion at 12 months

  The primary endpoint will be analyzed based on a Finkelstein-Schoenfeld/win-ratio approach, comparing pairs of subjects on the components of the composite endpoint in a hierarchical fashion: 1. Freedom from amputation 2. Freedom from CD-TLR 3. Primary Patency

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (24)

• Device Success

  Measured upon completion of the index procedure

• Procedural Success

  Measured upon completion of the index procedure

• Clinical Success

  Measured upon completion of the index procedure prior to discharge.

• Secondary Duplex Ultrasound Imaging Measures

  Measured at Hospital Discharge (12-24 hours post-procedure or prior to discharge, whichever comes first), 30 days, and 6, 12, 24 months

• Primary sustained clinical improvement

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

Study Arms (2)

Auryon Atherectomy System and Balloon Angioplasty

EXPERIMENTAL

Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty

Device: Auryon Atherectomy System

Balloon Angioplasty Only

ACTIVE COMPARATOR

Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.

Device: Balloon Angioplasty

Interventions

Auryon Atherectomy System DEVICE

Auryon Atherectomy System is composed of a laser and catheter

Auryon Atherectomy System and Balloon Angioplasty

Balloon Angioplasty DEVICE

Balloon Angioplasty alone

Balloon Angioplasty Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of subject is ≥ 18.
• Estimated life expectancy ≥1 year.
• Subject is able and willing to comply with all assessments in the study.
• Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
• Rutherford Category classification of 4 or 5 of the target limb.
• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines.
• Target lesion that is located in a native, de novo infra-popliteal artery (extending from P3 of the popliteal artery to the margin of the ankle mortise).
• Target lesions(s) must be viewed angiographically and have 50-100% stenosis.
• Only a single lesion is included in the study per subject.
• The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).
• Lesion length ≥50mm and ≤300mm.
• Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator's discretion.
• Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.

You may not qualify if:

• Target lesion is in a vessel graft or synthetic graft.
• Treatment of target lesion with radial access.
• Planned target limb major amputation (above-the-ankle).
• Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
• History of prior endovascular or surgical procedure on the index limb within 30 days prior to enrollment or planned within 30 days of the index procedure.
• Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
• Subject has a known coagulopathy or has bleeding diatheses/disorder, thrombocytopenia with platelet count less than 100,000/microliter / less than 80,000K.
• Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Myocardial infarction within 60 days prior to enrollment.
• History of stroke/CVA/TIA within 60 days prior to enrollment.
• History of thrombolytic therapy within 14 days of enrollment.
• Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, or is on dialysis.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the study requirements and evaluations pre- and post-treatment.

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (9)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85204, United States

RECRUITING

Kaiser Permanente

San Diego, California, 92123, United States

RECRUITING

CIS Grey ASC

Gray, Louisiana, 70359, United States

RECRUITING

MedStar Health Research Institute

Baltimore, Maryland, 21218, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

The Washington University

St Louis, Missouri, 63110, United States

RECRUITING

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Prisma Heath-University Medical Group

Greenville, South Carolina, 29601, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Anna Quillin

CONTACT

2196281806; anna.quillin@angiodynamics.com

Liz Manning

CONTACT

liz.manning@angiodynamics.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 16, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 8, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)