Actively Recruiting
Randomized Controlled Trial of the Auryon Atherectomy System Combined With Standard Balloon Angioplasty Versus Balloon Angioplasty Alone for Treating Lower Limb Blockages in Critical Limb Ischemia
Led by Angiodynamics, Inc. · Updated on 2026-01-08
224
Participants Needed
9
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Auryon Atherectomy System combined with balloon angioplasty compared to balloon angioplasty alone in treating blockages in the lower limbs, specifically in patients with critical limb ischemia. The study aims to determine if using the Auryon system improves outcomes such as reducing death, amputation, and the need for additional procedures while maintaining blood vessel openness. Participants will be randomly assigned to one of two groups: one group will receive treatment with the Auryon Atherectomy System followed by balloon angioplasty, while the other group will receive balloon angioplasty alone. The Auryon system includes a laser and catheter device. The trial includes an observational study for patients who do not meet the criteria for randomization but are treated with the Auryon system. Treatments and follow-up extend up to 24 months after the procedure. Throughout the study, participants will undergo various assessments including imaging tests like duplex ultrasound at hospital discharge, and at 30 days, 6, 12, and 24 months. Researchers will measure clinical improvements, limb amputation rates, blood flow indexes, wound healing, quality of life, and major adverse limb and cardiovascular events. The primary outcome compares groups on a combined set of measures at 12 months. Safety and device success are also monitored during and after the procedures.
CONDITIONS
Brief 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 218 years or older
- Estimated life expectancy of at least 1 year
- Willing and able to comply with all study assessments
- Provided informed consent by signing the approved form
- Rutherford Category 4 or 5 classification for the target limb
- Suitable candidate for angiography and endovascular intervention
- Target lesion is a native, de novo infra-popliteal artery with 50-100% stenosis
- Single lesion per subject included in the study
- Vessel segment distal to lesion is patent to the ankle with no significant lesions
- Lesion length between 50mm and 300mm
- Successful intraluminal crossing of the lesion
- Target lesion vessel diameter between 1.5mm and 4.5mm as estimated by investigator
You will not qualify if you...
- Target lesion located 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 for the target limb
- Prior endovascular or surgical procedure on the index limb within 30 days before or planned within 30 days after enrollment
- Pregnant or breastfeeding (females must have negative pregnancy test within 7 days before procedure)
- Known coagulopathy, bleeding disorders, or thrombocytopenia with low platelet counts
- Contraindication to antiplatelet or anticoagulant therapy
- Known allergy to contrast agents or medications used for the procedure 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
- Thrombolytic therapy within 14 days prior to enrollment
- Acute or chronic renal disease with serum creatinine >2.5 mg/dL or dialysis
- Participation in other investigational studies not reaching primary endpoint
- Other medical, social, or psychological issues that may interfere with study participation
- Ongoing cardiac problems deemed unsuitable by investigator
- Evidence of intracranial or gastrointestinal bleeding within past 3 months
- Failure to treat significant inflow lesions with less than 50% residual stenosis prior to target lesion treatment
- Residual stenosis or serious angiographic complications before investigational device use
- Use of adjunctive devices other than Auryon laser catheter or PTA devices except bailout stents
- In observational study: conditions making patient inappropriate for Auryon use per instructions or investigator
- Already enrolled in other interventional investigational studies that interfere with endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure care
Participants receive treatment with either the Auryon Atherectomy System combined with Balloon Angioplasty or Balloon Angioplasty alone to treat lower limb blockages.
1 procedure visit (in-person)
Duration - Up to 24 months
Participants are monitored through follow-up visits to assess clinical outcomes, wound healing, and device success over time.
Visits at hospital discharge, 30 days, 6, 12, and 24 months
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
L
Liz Manning
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here