Actively Recruiting
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
Led by Angiodynamics, Inc. · Updated on 2026-01-08
224
Participants Needed
9
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of subject is 65 18.
- Estimated life expectancy 651 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 located in a native, de novo infra-popliteal artery (from P3 of the popliteal artery to ankle mortise).
- Target lesion(s) visible angiographically with 50-100% stenosis.
- Only a single lesion included per subject.
- Vessel segment distal to the lesion patent to the ankle with no significant lesion (65 50% stenosis).
- Lesion length between 50mm and 300mm.
- Intraluminal crossing of the lesion confirmed.
- Target lesion reference vessel diameter between 1.5mm and 4.5mm by investigator estimate.
You will not qualify if you...
- Target lesion in a vessel graft or synthetic graft.
- Treatment of target lesion via radial access.
- Planned major amputation above the ankle on the target limb.
- Acute limb ischemia or thrombolysis as primary treatment of target limb.
- Prior endovascular or surgical procedure on index limb within 30 days before or planned within 30 days after enrollment.
- Pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test 64 7 days before procedure.
- Known bleeding disorders, coagulopathy, or thrombocytopenia with platelet count <100,000/microliter or <80,000K.
- Contraindication to antiplatelet or anticoagulant therapy.
- Known allergy to contrast agents or medications used in endovascular intervention that cannot be pre-treated.
- Myocardial infarction within 60 days prior to enrollment.
- History of stroke, cerebrovascular accident, or transient ischemic attack within 60 days prior to enrollment.
- Thrombolytic therapy within 14 days of enrollment.
- Acute or chronic renal disease with serum creatinine >2.5 mg/dL or >220 umol/L, or on dialysis.
- Participation in another investigational study that has not reached primary endpoint.
- Other medical, social, or psychological problems that preclude treatment or study evaluations.
- Ongoing cardiac problems judged unsuitable by investigator.
- Evidence of intracranial or gastrointestinal bleeding within past 3 months.
- Failure to treat clinically significant inflow lesions with <50% residual stenosis and no serious angiographic complications prior to target lesion treatment.
- Residual stenosis or serious angiographic complications prior to investigational device use.
- Use of adjunctive devices other than the Auryon laser catheter and/or PTA devices, except bailout stents for certain dissections.
- For observational study: medical conditions making treatment with Auryon system inappropriate, pregnancy or breastfeeding, or enrollment in other investigational interventional studies interfering with endpoints.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States, 85204
Actively Recruiting
2
Kaiser Permanente
San Diego, California, United States, 92123
Actively Recruiting
3
CIS Grey ASC
Gray, Louisiana, United States, 70359
Actively Recruiting
4
MedStar Health Research Institute
Baltimore, Maryland, United States, 21218
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
The Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
8
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
9
Prisma Heath-University Medical Group
Greenville, South Carolina, United States, 29601
Actively Recruiting
Research Team
A
Anna Quillin
CONTACT
L
Liz Manning
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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