Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone (AMBITION BTK)

Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Diseases
• Intervention / Treatment: Device: Auryon Atherectomy System; Device: Balloon Angioplasty

Detailed Description

Up to 1500 subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for, and be enrolled in, the observational study.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Liz Manning; Email: liz.manning@angiodynamics.com
• Study Contact Backup: Name: Anna Quillin; Phone Number: 2196281806; Email: anna.quillin@angiodynamics.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85204
      • Recruiting
      • Abrazo Arizona Heart Hospital
      • Contact: Ryleigh Alfonso; Phone Number: 480-433-7311; Email: ryleigh.alfonso@axsendoclinical.com
      • Principal Investigator: Stephen Smith, MD
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Kaiser Permanente
      • Contact: Michael Fechter; Phone Number: 858-266-6604; Email: michael.d.fechter@kp.org
      • Principal Investigator: Michael Girard, MD
  • Louisiana
    • Gray, Louisiana, United States, 70359
      • Recruiting
      • CIS Grey ASC
      • Contact: Deanna Benoit; Phone Number: (985) 873-5613; Email: deanna.benoit@cardio.com
      • Principal Investigator: Craig Walker, M.D
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Medstar Health Research Institute
      • Contact: Keith Moyer; Phone Number: 443-278-9170; Email: keith.t.moyer@medstar.net
      • Principal Investigator: Jason Crowner, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Anahita Dua, MD
      • Contact: Jaimie Atwood; Phone Number: 617-726-2264; Email: jlattwood@mgh.harvard.edu
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • The Washington University
      • Contact: Isabella Mineiro; Email: mineiro@wustl.edu
      • Principal Investigator: Carlos Guevara, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina Chapel Hill
      • Contact: Amber Daino; Email: amber_fix@med.unc.edu
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Principal Investigator: Jun Li, MD
      • Contact: Christopher Ernst; Phone Number: 216-844-7637; Email: christopher.ernst@uhhospitals.org
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Recruiting
      • Prisma Heath-University Medical Group
      • Principal Investigator: Sagar Gandhi, MD
      • Contact: Maggie Salle; Phone Number: 864-607-3405; Email: margaret.salle@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Angiographic Inclusion Criteria

• 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.

Exclusion Criteria:

• 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.
• Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.
• Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months.

Angiographic Exclusion Criteria

• Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with <50% residual stenosis with no serious angiographic complications (e.g., embolism or dissection) prior to treatment of the target lesion.
• Residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
• The use of adjunctive devices to treat the target lesion other than the investigative Auryon laser catheter and/or PTA devices, such as scoring balloons, drug-eluting balloons, re-entry devices, lithotripsy devices, or other atherectomy devices (with the exception of bailout stents for Class C/D dissections).

Subjects that do not meet eligibility criteria for the randomized controlled trial are eligible to be enrolled in the observational study.

Observational Study Inclusion Criteria:

• Subjects intended to be treated with the Auryon Atherectomy System for de-novo, restenotic or ISR lesions of the infra-popliteal arteries.
• Subjects presenting with symptomatic PAD with claudication or CLI by Rutherford Category 2 - 6 of the target limb.
• Age of subject is ≥ 18.
• Subject has been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.

Observational Study Exclusion Criteria:

• Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Auryon Atherectomy System as per Instructions for Use (IFU) or investigator's opinion.
• 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 is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auryon Atherectomy System and Balloon Angioplasty; Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty	Device: Auryon Atherectomy System; Auryon Atherectomy System is composed of a laser and catheter
Active Comparator: Balloon Angioplasty Only; Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.	Device: Balloon Angioplasty; Balloon Angioplasty alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Freedom from amputation; Freedom from CD-TLR; Primary Patency	From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Successful delivery, lesion crossing, functionality and retrieval of the investigational device	Measured upon completion of the index procedure
Procedural Success	Defined as device success and residual diameter stenosis ≤30% on completion angiography without flow-limiting dissection (≥ grade D), perforation or distal embolization, all assessed by core lab on angiography.	Measured upon completion of the index procedure
Clinical Success	Defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.	Measured upon completion of the index procedure prior to discharge.
Secondary Duplex Ultrasound Imaging Measures	Subsegmental analysis: proportion of segments with binary restenosis (diameter stenosis of >50% or PSVR ≤ 2.5) on core lab-adjudicated DUS.	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	Defined as freedom from target limb major amputation, CD-TLR and increase in Rutherford category from baseline.	Measured at 30 days, and 6, 12, 24 months
Secondary Sustained Clinical Improvement	Defined as freedom from target limb major amputation and increase in Rutherford category from baseline.	Measured at 30 days, and 6, 12, 24 months
Major Amputation	Defined as above-the-ankle amputation of the target limb.	Measured at 30 days, and 6, 12, 24 months
Amputation-free survival	Defined as freedom from all-cause mortality and major amputation.	Measured at 30 days, and 6, 12, 24 months
Primary Assisted Patency	Defined as freedom from Duplex ultrasound core laboratory (DCL)-adjudicated loss of patency (defined as ≥50% stenosis) irrespective of interventions for stenoses intended to maintain functionality and patency (defined as stenosis ≤50%)	Measured at 30 days, and 6, 12, 24 months
Secondary Patency	Defined as freedom from loss of patency (defined as ≥50% stenosis) as determined by the DCL irrespective of interventions for stenoses intended to reestablish functionality and patency (defined as stenosis ≤50%	Measured at 30 days, and 6, 12, 24 months
Clinically Driven Target Vessel Revascularization (CD-TVR)	Defined as re-intervention on target vessel due to recurrent/persistent/worsening symptoms and the Duplex ultrasound finding of ≥ 50% restenosis of target vessel by DCL measurement.	Measured at 30 days, and 6, 12, 24 months
Rutherford Caregory	Defined as change in Rutherford category (0 asymptomatic -6 major tissue loss) from baseline.	Measured at 30 days, and 6, 12, 24 months
Ankle Brachial Index/Toe-Brachial Index	Defined as change in Ankle-Brachial Index (ABI), or if unevaluable, Toe-Brachial index (TBI) from baseline.	Measured at 30 days, and 6, 12, 24 months
Quality of Life (QOL)	Defined as change in Quality of Life (QOL) measures from baseline: - Walking Impairment Questionnaire (WIQ) - Defined as change in walking impairment questionnaire (WIQ) measures from baseline.	Measured at 30 days, and 6, 12, 24 months
Rate of Major Adverse Limb Events	Defined as the composite of major amputation or major reintervention (new bypass graft, jump/interposition graft revision, thrombectomy/thrombolysis) of the index limb.	Measured at 30 days, and 6, 12, 24 months
Rate of major cardiovascular event	Defined as the composite of cardiovascular death, myocardial infarction (MI), and stroke.	Measured at 30 days, and 6, 12, 24 months
All-Cause Mortality		Measured at 30 days, and 6, 12, 24 months
Wound Healing	Defined as investigator-reported status of each index wound compared to baseline. Descriptive categories to be captured: 1) Improved 2) Unchanged 3) Worse 4) Healed/Complete Closure	Measured at 30 days, and 6, 12, 24 months
Wound, Ischemia, foot Infection (WIfI) Classification	Defined as the change in total WIfi score from baseline	Measured at Discharge, 30 days, and 6, 12, 24 months
Bailout Stenting	Bailout stenting will be allowed for: 1) flow-limiting Class C/D dissections or vessel perforations that are not amenable to two prolonged balloon inflations (≥ 2 min each); 2) acute vessel recoil or other negative occlusive complication that results in severely decreased vessel blood flow; or 3) persistent residual stenosis ≥30% by visual estimate after multiple prolonged balloon inflations.	Measured upon completion of the index procedure prior to discharge.
Intravascular Imaging (IVI) analysis	- Vessel calcification will be graded by IVI at baseline using the Fanelli classification.	Measured during the index procedure
Quality of Life (QOL)	Defined as change in Quality of Life (QOL) measures from baseline: - EQ-5D - Defined as change in health-related quality of life, encompassing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Measured at 30 days, and 6, 12, 24 months
Intravascular Imaging (IVI) analysis	- Minimal luminal area (MLA) gain at the lesion site will be measured by IVI and calculated between after vessel prep prior to intervention, post-laser and post-PTA in the treatment arm, and after vessel prep prior to intervention and post-final adjunctive therapy in the control arm.	Measured during the index procedure
Intravascular Imaging (IVI) analysis	- Dissections on IVI images will be classified using the iDissection classification	Measured during the index procedure

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Angioplasty; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Angioplasty, Balloon
• Other Study ID Numbers: 2024-RFT-A-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes