N/A
N=102
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
Infrainguinal Peripheral Artery Disease · Peripheral Arterial Disease · PAD
Bottom Line
View on ClinicalTrials.gov: NCT04229563 ↗Enrolled (actual)
102
Serious AEs
26.5%
Results posted
May 2026
Primary outcome: Primary: Primary Efficacy: Acute Procedural Success — 69 Lesions
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AURYON Atherectomy System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Angiodynamics, Inc.
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy: Acute Procedural Success |
69 | — |
| PRIMARY Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE) |
97 | — |
| SECONDARY Number of Participants With Device Related Complications Requiring Intervention |
5 | — |
| SECONDARY Number of Participants With Major Adverse Events (MAEs) Over Time |
3; 9; 10; 13 | — |
| SECONDARY Number of Patent Lesions |
49; 48; 37 | — |
| SECONDARY Freedom From Occlusion |
17; 15 | — |
| SECONDARY Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI) |
0.61; 1.05; 0.81 | — |
| SECONDARY Change From Baseline in Walking Impairment Questionnaire (WIQ) |
20.74; 20.02; 13.72 | — |
| SECONDARY Change From Baseline in Rutherford Clinical Category (RCC) |
-1.80; -2.24; -2.19 | — |
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 market.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04229563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.