Infrainguinal Peripheral Artery DiseasePATHFINDERNCT04229563
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
An observational study of Infrainguinal Peripheral Artery Disease and Peripheral Arterial Disease, run by Angiodynamics, Inc. at 10 sites in United States.
Trial summary
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- What is being tested?
- AURYON Atherectomy System
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 10 sitesUnited States
- Study dates
- 4 Aug 2020to 17 Apr 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with infra-inguinal PAD undergoing atherectomy with the AURYON Atherectomy System.
Who may be able to join
- Subject is ≥ 18 years old.
- Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease.
- Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ).
- Subject is capable and willing to comply with the scheduled follow up
- Subject is able and willing to sign a written Informed Consent Form (ICF).
Who cannot join
- Target lesion is in an arterial bypass.
- Planned use of another atherectomy device in the same procedure
- Co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study.
- Participating in another study on an interventional non-cleared device, that could impact the study results
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Rush University Medical Center
Chicago, Illinois, 60612
NJ Endovascular Amputation Prevention
Clifton, New Jersey, 07013
Medical City Heart and Spine
Dallas, Texas, 75243
Comprehensive Cardiovascular
Davenport, Florida, 33837
Midwest Cardio. research foundation
Davenport, Iowa, 52803
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Amavita Clinical Research
Miami, Florida, 33169
Hurricane Cardiology
New Braunfels, Texas, 78130
Pulse Cardiovacular
Scottsdale, Arizona, 85259
Pima Vascular
Tucson, Arizona, 85718
About this study
Official title: PATHFINDER Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (EX-PAD-05)
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the market.
Read the detailed description
US multicenter, prospective, single-arm, observational post market Registry. A pilot registry aimed to evaluate the safety and efficacy of Auryon Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market.
- Being tested
- AURYON Atherectomy System
- Keywords
- Peripheral Artery Disease, Peripheral Occlusive Disease, Peripheral Artery Stenonsis, Artery Restenosis, Arterial Occlusive Disease, Peripheral Vascular disease, Laser recanalization, Endovascular treatment or Procedure or Surgery, Calcified Lesions, Atherectomy, Intermittent Claudication, Claudication pain, Arterial Calcification, Critical Limb Ischemia, CLI, Acute Limb Ischemia, Acute Arterial Occlusion, Infra-inguinal Stenosis or Occlusion, Femoral Artery Stenosis, Femoral-Popliteal Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Intermittent Claudication, Chronic Limb-Threatening Ischemia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURYON Atherectomy SystemDevice
The AURYON Atherectomy System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Eligible PAD patients who are routinely treated with atherectomy by AURYON Atherectomy System. Receives: Device: AURYON Atherectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy: Acute Procedural Success
Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.
Measured: Peri-procedural (by the end of the index procedure)
Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE)
Percentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge.
Measured: Through discharge, an average of 5 days
Secondary outcomes (7)
Number of Participants With Device Related Complications Requiring Intervention
Number of participants with device related complications requiring intervention, defined as peri procedural Major Adverse Events (MAEs), reported by the operating physician as caused directly due to the use of the AURYON device.
Measured: Till discharge, an average of 5 days
Number of Participants With Major Adverse Events (MAEs) Over Time
Number of participants with post-discharge MAEs over time; defined as: (a) Unplanned target limb amputation, (b) cardiovascular death, (c) clinically driven target lesion revascularization, (d) target vessel revascularization (TVR).
Measured: Post-discharge (at 30-days, 6-, 12-, and 24-months)
Number of Patent Lesions
Number of patent lesions, defined as <50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of <2.5, as assessed quantitatively by Duplex ultrasonography (DUS), at 6, 12, and 24 months.
Measured: Post-discharge (at 6-, 12-, and 24-months)
Freedom From Occlusion
Number of below-the-knee (BTK) lesions with freedom from occlusion (100% stenosis by DUS) combined with freedom from clinically-driven target lesion revascularization (CD-TLR)
Measured: Post-discharge (at 6-, 12-, and 24-months)
Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI)
Change in ankle brachial index (ABI) or tibial brachial index (TBI) if ABI unavailable at 6, 12, and 24, months, compared to baseline.
Ankle-Brachial Index (ABI) is an ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs and feet; 0.4-0.9 indicates mild-moderate peripheral artery disease (PAD); 0.4 and lower indicates severe PAD. Positive change between timepoints represents a clinical improvement over time.
Measured: Post-discharge (at 6-, 12-, and 24-months)
Change From Baseline in Walking Impairment Questionnaire (WIQ)
Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline.
WIQ is a patient reported outcome (survey) to grade physical ability representing PAD progress. It has 3 sub-scales (walking speed, distance, climbing stairs), with the total score ranging between 0-100. A higher score means less impairment; positive change between timepoints represents a clinical improvement through time.
Measured: Post-discharge (at 6-, 12-, and 24-months)
Change From Baseline in Rutherford Clinical Category (RCC)
Change in Rutherford Clinical Category at 6, 12, and 24, months, compared to baseline.
Rutherford Category is a physician-assessed measurement, with 7 stages (0= Asymptomatic to 6= Severe ischemic ulcers/frank gangrene) representing PAD progress. Lower value means less impairment. Positive difference between timepoints represents a clinical deterioration over time.
Measured: Post-discharge (at 6-, 12-, and 24-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 Aug 2020
- Primary completion17 Mar 2021
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infrainguinal Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TBD TBD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229563
- Sponsor's protocol ID
- EX-PAD-05
- Acronym
- PATHFINDER
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2020
- Last updated
- 18 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Das TS, Shammas NW, Yoho JA, Martinez-Clark P, Ramaiah V, Leon LR, Pacanowski JP, Tai Z, Ali V, Arslan B, Rundback J. Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry. Catheter Cardiovasc Interv. 2024 May;103(6):949-962. doi: 10.1002/ccd.31023. Epub 2024 Apr 2.
PubMed 38566525