NCT06777901 · Angiodynamics, Inc.
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
(AMBITION BTK)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Auryon Atherectomy System
Auryon Atherectomy System is composed of a laser and catheter
DEVICE
Balloon Angioplasty
Balloon Angioplasty alone
Primary outcome measures
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
Time frame: From enrollment to the end of treatment 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. 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.
Where
- Phoenix, Arizona
- San Diego, California
- Gray, Louisiana
- Baltimore, Maryland
- Boston, Massachusetts
- St Louis, Missouri
- Chapel Hill, North Carolina
- Cleveland, Ohio
- Greenville, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations