A Phase 4 interventional study of Auryon Atherectomy System and Balloon Angioplasty in Peripheral Arterial Diseases, sponsored by Angiodynamics, Inc.. Recruiting at 9 sites in United States. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Angiodynamics, Inc. · Phase 4, Interventional, and Treatment
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.
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 224 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Angiodynamics, Inc. is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Angiographic Inclusion Criteria
Exclusion Criteria:
Angiographic Exclusion Criteria
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:
Observational Study Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty
Device: Auryon Atherectomy System
Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.
Device: Balloon Angioplasty
Auryon Atherectomy System is composed of a laser and catheter
Balloon Angioplasty alone
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
Time frame: From enrollment to the end of treatment at 12 months
Device Success
Successful delivery, lesion crossing, functionality and retrieval of the investigational device
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 30 days, and 6, 12, 24 months
Major Amputation
Defined as above-the-ankle amputation of the target limb.
Time frame: Measured at 30 days, and 6, 12, 24 months
Amputation-free survival
Defined as freedom from all-cause mortality and major amputation.
Time frame: 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%)
Time frame: 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%
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 30 days, and 6, 12, 24 months
All-Cause Mortality
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured during the index procedure
Intravascular Imaging (IVI) analysis
\- Dissections on IVI images will be classified using the iDissection classification
Time frame: Measured during the index procedure
Plan to share: No
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