Peripheral Arterial DiseasesPhase 4AMBITION BTKNCT06777901
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
A Phase 4 study testing Auryon Atherectomy System and Balloon Angioplasty in people with Peripheral Arterial Diseases, run by Angiodynamics, Inc. at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Diseases
- What is being tested?
- Auryon Atherectomy System and Balloon Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Apr 2025to Apr 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Liz Manning contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
MedStar Health Research Institute
Baltimore, Maryland, 21218
Keith Moyer, 443-278-9170, keith.t.moyer@medstar.net
Jason Crowner, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jaimie Atwood, 617-726-2264, jlattwood@mgh.harvard.edu
Anahita Dua, MD
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Amber Daino, amber_fix@med.unc.edu
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Christopher Ernst, 216-844-7637, christopher.ernst@uhhospitals.org
Jun Li, MD
- Recruiting
CIS Grey ASC
Gray, Louisiana, 70359
Deanna Benoit, (985) 873-5613, deanna.benoit@cardio.com
Craig Walker, M.D
- Recruiting
Prisma Heath-University Medical Group
Greenville, South Carolina, 29601
Maggie Salle, 864-607-3405, margaret.salle@prismahealth.org
Sagar Gandhi, MD
- Recruiting
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85204
Ryleigh Alfonso, 480-433-7311, ryleigh.alfonso@axsendoclinical.com
Stephen Smith, MD
- Recruiting
Kaiser Permanente
San Diego, California, 92123
Michael Fechter, 858-266-6604, michael.d.fechter@kp.org
Michael Girard, MD
- Recruiting
The Washington University
St Louis, Missouri, 63110
Isabella Mineiro, mineiro@wustl.edu
Carlos Guevara, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Arterial Diseases
- Being tested
- Auryon Atherectomy System, Balloon Angioplasty
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auryon Atherectomy SystemDevice
Auryon Atherectomy System is composed of a laser and catheter
Balloon AngioplastyDevice
Balloon Angioplasty alone
| Study group | Role | What they receive |
|---|---|---|
| Auryon Atherectomy System and Balloon Angioplasty | Experimental | Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty Receives: Device: Auryon Atherectomy System |
| Balloon Angioplasty Only | Active comparator | Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only. Receives: Device: Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (24)
Device Success
Successful delivery, lesion crossing, functionality and retrieval of the investigational device
Measured: 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: 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: 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: 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: 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: Measured at 30 days, and 6, 12, 24 months
Major Amputation
Defined as above-the-ankle amputation of the target limb.
Measured: Measured at 30 days, and 6, 12, 24 months
Amputation-free survival
Defined as freedom from all-cause mortality and major amputation.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: Measured at 30 days, and 6, 12, 24 months
All-Cause Mortality
Measured: 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: 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: 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: 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: 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: 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: Measured during the index procedure
Intravascular Imaging (IVI) analysis
- Dissections on IVI images will be classified using the iDissection classification
Measured: Measured during the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start21 Apr 2025
- Primary completionFeb 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777901
- Sponsor's protocol ID
- 2024-RFT-A-01
- Acronym
- AMBITION BTK
- Status last verified
- May 2025
- First submitted
- 7 Jan 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No