Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
NCT ID: NCT06777901
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
224 participants
INTERVENTIONAL
2025-04-21
2029-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial
NCT04760119
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
NCT01870401
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
NCT06122974
Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity
NCT02043951
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
NCT01330628
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Auryon Atherectomy System and Balloon Angioplasty
Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty
Auryon Atherectomy System
Auryon Atherectomy System is composed of a laser and catheter
Balloon Angioplasty Only
Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.
Balloon Angioplasty
Balloon Angioplasty alone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Auryon Atherectomy System
Auryon Atherectomy System is composed of a laser and catheter
Balloon Angioplasty
Balloon Angioplasty alone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Angiodynamics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
Kaiser Permanente
San Diego, California, United States
CIS Grey ASC
Gray, Louisiana, United States
MedStar Health Research Institute
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Washington University
St Louis, Missouri, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Prisma Heath-University Medical Group
Greenville, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-RFT-A-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.