Trial ID: PROMISE III

Can Rerouting Blood Through Your Veins Save Your Leg When You've Run Out of Options?

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.

status: recruiting

Trial Highlights & Innovative Features

① WHO CAN JOIN?

For People With No Other Options Left to Save Their Leg

This study is for people with a severe form of PAD called chronic limb-threatening ischemia (CLTI). This means blood flow to your leg is so low that you have pain even at rest, or you have a wound or sore on your foot that will not heal. To join, doctors must have already told you that a normal artery procedure or surgery will not work for you. You must also be between 18 and 95 years old and have a wound care team helping you. Researchers want to find a new way to get blood back into the foot and help people keep their leg.

② WHAT IS BEING STUDIED?

testing a New Way to Get Blood Back Into Your Foot

Doctors are studying one treatment:

The LimFlow® System, a device placed inside your body without open surgery.

Instead of fixing the blocked artery, this device creates a new path so blood flows through a nearby vein and reaches your foot that way.

The goal is to see if this new path can heal wounds, ease pain, and help people keep their leg when nothing else has worked.

③ What Are Researchers Looking For?

Researchers will see whether the laser treatment helps patients:

Avoid major amputation

Keep the treated artery open longer

Need fewer repeat procedures

Patients will be followed for 2 years after treatment.

Can This Treatment Improve Long-Term Results?

④ How Does the Study Work?

Participants are randomly placed into one of the two treatment groups, much like flipping a coin.

Participants Are Randomly Assigned

This helps researchers make a fair comparison to learn which treatment works best.

Trial Eligibility Criteria

You May Qualify If:

Are 18 years of age or older
Have been diagnosed with Peripheral Artery Disease (PAD)
Have a blocked artery below the knee
Have pain in your foot or leg even while resting
Have a foot ulcer, wound, or sore that is slow to heal
Have been told you have critical limb ischemia (CLTI) or chronic limb-threatening ischemia
Are being evaluated for a minimally invasive procedure to improve blood flow
Are able to undergo an angiogram and endovascular treatment if recommended by your doctor
Have not had a recent procedure on the same leg within the past 30 days
Are willing to attend follow-up visits after your procedure
Are willing to answer questions about your health during the study
Are interested in helping researchers improve future treatments for people living with PAD

You May NOT Qualify If:

Need an emergency (above-the-ankle) amputation
Have sudden (acute) loss of blood flow to your leg requiring emergency clot-busting treatment
Had a heart attack or stroke within the past 2 months
Are on dialysis or have severe kidney disease
Cannot safely receive blood-thinning medications or contrast dye used during angiography
Are pregnant or breastfeeding
Are currently enrolled in another clinical trial that would interfere with this study
Have another serious medical condition that your study doctor believes would make participation unsafe

click here for more additional criteria & trial details: on ClinicalTrials.gov

Auryon Laser Animation

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.