Trial ID: Ambition
Advanced Limb Salvage & Revascularization Study
Multicenter, prospective, randomized (1:1) controlled trial (RCT) comparing the Auryon Atherectomy System (355-nm UV laser) plus standard balloon angioplasty (PTA) versus PTA alone for below-the-knee (BTK) infrapopliteal lesions in patients with CLTI. First patient enrolled July 2025. Companion registry enrolling up to 1,500 additional infrainguinal PAD patients treated with Auryon who do not meet RCT criteria. The Auryon System has treated over 100,000 patients and is the only 355-nm solid-state laser atherectomy platform on the market.
About The Company : Angiodynamics...... This landmark trial focuses on clinical outcomes that matter most to patients: wound healing, pain reduction, and amputation-free survival. By participating, you help establish new standards for PAD care and limb preservation techniques that will inform medical choices for generations to come. This trial is currently seeking participants who have been diagnosed with advanced PAD or CLTI.
Trial Highlights & Innovative Features
Who Can Join?
For People at High Risk of Limb Loss
This study is for people with severe peripheral artery disease (PAD) below the knee who have pain at rest or wounds that are not healing. Researchers want to find better ways to restore blood flow and help save limbs.
Primary Study Goal
Focusing on 12-month patency and freedom from TLR, this study aims to set a new benchmark for limb salvage in complex CLTI cases.
Innovative Imaging
Utilizing high-resolution OCT imaging to measure real-time vessel response during the procedure for unparalleled precision.
Broad Patient Inclusion
Designed to be inclusive of real-world patient populations, including those with end-stage renal disease and calcified lesions often excluded from other studies.
Trial Eligibility Criteria
Inclusion Criteria
- Diagnosed Peripheral Artery Disease (PAD) in one or both legs
- Aged 18 to 85 years at the time of screening
- Symptoms of intermittent claudication or resting leg pain
- Willingness to comply with all study procedures and follow-up visits
- Stable medication regimen for at least 30 days prior to enrollment
Exclusion Criteria
- Previous major amputation in the target limb
- History of severe heart failure or recent myocardial infarction
- Uncontrolled diabetes mellitus with glucose levels above target
- Active infection or malignancy requiring systemic therapy
- Currently participating in another interventional clinical trial
"Participating in this trial gave me access to specialized vascular care that wasn't available elsewhere. It feels good to know my journey might help others facing PAD in the future." — PAD Trial Participant
Listed on ClinicalTrials.gov
Urgent Support
For more information on this study, or to get assessed for it, call the Global PAD Association Leg Saver Hotline.
Speak with a PAD Navigator today to understand your options and secure your spot in a clinical trial near you. Our experts are ready to assist you in navigating your care pathway.