Peripheral Artery Disease Clinical Trials — A Patient's Guide

What is peripheral artery disease?

Peripheral artery disease (PAD) is the narrowing of the arteries that carry blood to your legs, usually caused by atherosclerosis — the same plaque buildup that causes heart attacks and strokes. When leg arteries get narrow, the muscles in the legs do not get enough oxygen, especially during activity.

Patients with PAD usually fall into one of three groups:

• Asymptomatic PAD — narrowed arteries show up on testing, but you do not feel the classic symptoms. This is more common than people realize.
• Intermittent claudication — cramping, aching, or fatigue in the calf, thigh, or buttock when walking, that goes away with rest. This is the most common symptom.
• Critical limb-threatening ischemia (CLTI) — the most severe form. Pain in the foot at rest, slow-healing wounds, ulcers, or tissue loss. CLTI carries a real risk of amputation if blood flow is not restored.

PAD also has anatomic sub-categories that matter for trial eligibility, because most device trials are designed for a specific part of the leg:

• Iliac — the large arteries in the pelvis
• Femoropopliteal — the artery running down the thigh and behind the knee
• Below-the-knee (BTK) — the smaller arteries in the lower leg, often the hardest to treat
• CLTI — often involves multiple levels at once

Doctors also use the Rutherford classification (Categories 0-6) to describe how severe the symptoms are, from no symptoms to major tissue loss. Trials usually specify which Rutherford categories they enroll.

One more thing patients should know: PAD is a marker of body-wide atherosclerosis. People with PAD have a higher long-term risk of heart attack and stroke than people without PAD, even when their leg symptoms are mild. That is part of why trials in this space matter — they are looking at outcomes that go beyond the legs.

If you do not know your specific anatomy or Rutherford category, that is fine. The screening visit will check it. Bringing any prior leg ultrasound, CT angiogram (CTA), or angiogram results helps.

What PAD trials are testing in 2026

PAD research is unusually active right now. Current trials are exploring several directions at once:

• Atherectomy devices. These are catheter-based tools that shave, cut, or sand calcified plaque inside an artery. Several pivotal trials are running, including studies focused specifically on below-the-knee (BTK) anatomy, which is the hardest to treat with conventional balloons and stents.
• Drug-coated balloons (DCBs) and drug-eluting stents. These devices release medication into the artery wall during or after a procedure to slow the body's tendency to re-narrow the artery. Continuing trials are comparing newer DCBs and stents head-to-head.
• Bioresorbable scaffolds. Investigational scaffolds designed to support the artery for a period of time and then be absorbed by the body, leaving no permanent implant behind.
• New medications for atherosclerosis progression, claudication symptom relief, and wound healing in CLTI.
• Cell therapy trials for patients with CLTI who are not candidates for revascularization. These investigational therapies aim to encourage the growth of new small blood vessels.
• Combination revascularization approaches that pair atherectomy with drug-coated balloons or other technologies in a structured sequence to improve durability.

2026 is a particularly active year for BTK trials specifically. If your CTA or angiogram shows disease below the knee — or if you have CLTI involving below-the-knee anatomy — there are more trial options open to you than there were a few years ago.

A trial is not a guess. By the time a treatment reaches a Phase 2, Phase 3, or pivotal device study, it has already gone through earlier safety testing. The trial is asking a more specific question: does this work in real PAD patients, and is the risk reasonable for the potential benefit?

Who might be eligible

Every PAD trial has its own eligibility list. Some are narrow, some are broader. A few common requirements come up again and again:

• Documented PAD. Usually confirmed with the ankle-brachial index (ABI), arterial duplex ultrasound, CT angiogram (CTA), or a prior angiogram showing the disease.
• PAD in the anatomic location the trial is studying. A BTK trial enrolls only BTK disease; an iliac trial enrolls only iliac disease, and so on.
• A specific Rutherford classification range. Many trials focus on Rutherford 3 (severe claudication) and above, or on Rutherford 4-6 for CLTI-focused studies.
• Stable comorbidities. Conditions like diabetes, coronary disease, or kidney disease are often allowed if they are stable and well-managed; uncontrolled comorbidities may exclude you.
• Age range. Most adult PAD trials enroll ages 18-80 or 18-85; some have a higher upper limit.
• Ability to commit to procedural and follow-up visits. PAD device trials usually require a procedure plus several follow-up visits over 1-2 years.
• Not pregnant or planning pregnancy during the study, for relevant patients.

You may also be excluded for things like very poor kidney function (a problem because CTA and angiograms use contrast dye), severe allergy to contrast that cannot be premedicated, recent major surgery, or being enrolled in another investigational device study. None of these are personal — they are study-design decisions made to keep results clear and participants safe.

The honest reality: most patients who screen for any one trial do not end up enrolling in that specific trial. If the anatomy or Rutherford category does not match, we check whether another open study fits.

What participation involves

PAD trials usually involve a procedure, so the structure looks a little different from a medication-only trial.

Screening (1-3 hours)

You meet the trial team. The Principal Investigator — for PAD trials at Amavita Research, an interventional cardiologist with peripheral experience — reviews your history with you. Screening usually includes:

• Ankle-brachial index (ABI) measurement in both legs
• Review of any prior duplex ultrasound, CTA, or angiogram images
• A blood draw for kidney function and other labs
• Baseline walking-distance assessment if relevant
• A full review of your current medications and any allergies

You go through informed consent: a detailed document explaining what the trial is studying, what is involved, the known risks (including procedural risks), and your right to leave at any time. (For a section-by-section walkthrough, see our consent-form reading guide.)

Pre-procedure visit

If screening confirms eligibility, a pre-procedure visit covers final imaging review, medication adjustments (some blood thinners may be paused or started), pre-procedure labs, and instructions for the day of the procedure.

The procedure

Most PAD device trials involve an outpatient catheter-based procedure done in a cath-lab. You go home the same day in most cases. Procedures are typically performed under local anesthesia with light sedation, through a small puncture in the groin, arm, or sometimes the foot. The interventional cardiologist uses imaging guidance to reach the affected artery and deploy the investigational device.

Post-procedure follow-up

Follow-up is structured and usually runs at:

• 30 days (1 month) — clinic visit, ABI, walking assessment, wound check if applicable
• 6 months — repeat ABI, walking assessment, often duplex ultrasound, symptom and quality-of-life questionnaire
• 12 months — same as 6-month visit, sometimes with imaging (duplex, CTA, or angiogram per protocol)
• Some trials add 24-month and longer time points

Between visits you may keep a symptom diary or a walking-distance log. Phone check-ins are common, especially in the first few weeks after the procedure.

End-of-study and follow-up

At the end of the trial-defined follow-up period, you have a final visit. After that, you return to your regular cardiology, vascular, or primary care team for ongoing care.

What you might gain

Patients have different reasons for considering a PAD trial. Common ones:

• Access to investigational devices or treatments that are not yet available outside research.
• More thorough monitoring — repeat ABI, imaging, and walking assessments at structured time points that routine care does not always provide.
• Possible improvement in walking distance or symptom severity for some participants.
• For CLTI patients, possible limb salvage if revascularization is successful and wounds heal. This is a major reason CLTI patients consider trials when standard options have been exhausted.
• A meaningful contribution to research that may help future patients with PAD.

We want to be honest here: a procedure may help you, may not improve your symptoms, or in some cases may have complications. No one — not your cardiologist, not the trial team, not the sponsor — can promise benefit. That is exactly why the trial is being done: to find out.

What the risks are

PAD trials carry the standard risks of catheter-based procedures plus device-specific risks. The consent form covers all of these in detail. The most common categories:

• Procedural risks. Bleeding or bruising at the access site (groin, arm, or foot), vessel injury, blood clot at the access site, infection.
• Contrast-related risks. Kidney function can worsen after contrast dye exposure, especially in patients with pre-existing kidney disease. Allergic reactions to contrast can occur and are usually managed with premedication.
• Device-specific risks. Each investigational device has its own risk profile — for example, vessel perforation with atherectomy, embolization of plaque debris downstream, or device fracture. The consent form lists known device risks.
• Re-narrowing (restenosis). Even successful procedures do not always last. The artery can re-narrow over months to years. This is one of the things the trial is studying.
• Randomization to a control treatment. Many trials are designed so some participants receive the investigational device and some receive current standard care. You may not get the investigational treatment.
• Time commitment. Visits, labs, imaging, and walking assessments take time and energy.

You can withdraw at any time, for any reason, without it affecting your future medical care.

How to find out if you are eligible

There are three easy ways to start the conversation:

• Call (786) 703-5941. A 15-minute eligibility screening is free and does not commit you to anything.
• Use our patient contact form at /contact-patient.
• Have your cardiologist, vascular specialist, or primary care doctor refer you. We coordinate with most Miami-area cardiology and vascular practices.

Bring or be ready to share: any prior leg duplex ultrasound, CT angiogram, or angiogram report; a list of your current medications (especially blood thinners); any wound photos if you have CLTI; and your most recent labs if available.

Active PAD trials at Amavita Research

We currently have PAD protocols open at Amavita Research. As of the date on this page, an active study is:

• GREAT (Golazo® Peripheral Atherectomy) — a pivotal trial of the Golazo® peripheral atherectomy system for treatment of calcified lower-extremity arterial disease, sponsored by Avantec Vascular. See /trials/golazo-great for details.

The Principal Investigator is Dr. Pedro Martinez-Clark, MD, FACC, an interventional cardiologist with peripheral atherectomy experience.

For the current list of trials and contact information, see /therapeutic-areas/peripheral-artery-disease. Trial availability changes — call us for the most current status.

Questions worth asking before you join

The trial team welcomes these questions. If yours is not on the list, ask anyway.

• What is the chance I will receive the investigational device versus the control treatment? This is set by the trial design and the team can tell you.
• What happens if the procedure does not work, or my symptoms come back? The team explains your options, which may include a repeat procedure, a different revascularization approach, or other treatment depending on the situation.
• Does my anatomy actually fit this trial? This is checked at screening using your ABI, prior imaging, and sometimes a fresh angiogram. The PI will be honest if your anatomy is not a match.
• How will my regular cardiologist or vascular specialist be kept in the loop? With your permission, we send updates and study data to your regular team so your care stays coordinated.
• What is the recovery time? Most outpatient PAD procedures involve a short recovery — most patients walk the same day or the next day, with activity restrictions for a week or so. Specifics depend on the access site and the device.
• Can I keep the device or treatment if it works for me? Sometimes, depending on the program. Ask about post-trial access if it matters to you.
• Are there any costs to me? For most cardiovascular trials at Amavita Research, study-related care is paid for by the sponsor. Routine medical care is still billed to your insurance as usual.

A special note for CLTI patients

If you have critical limb-threatening ischemia — rest pain, non-healing foot wounds, ulcers, or tissue loss — and you have been told amputation may be on the table, it is worth a conversation about clinical trials before any irreversible decision. 2026 is an active year for novel atherectomy devices, drug-coated balloons designed for BTK anatomy, and cell therapies for patients who are not candidates for standard revascularization. None of these are guaranteed to save the limb, and not every patient is a candidate. But for some patients, a trial offers an option that does not exist outside research. Ask your vascular team, or call us directly.

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About the author: Amavita Research is a cardiovascular clinical trial site embedded inside amavita Heart and Vascular Health® in North Miami Beach, FL. Our PAD trials are led by Dr. Pedro Martinez-Clark, MD, FACC, an interventional cardiologist with peripheral atherectomy experience. We see patients in English, Spanish, Haitian Creole, and Brazilian Portuguese. Call (786) 703-5941 or visit /contact-patient.