Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
CompletedNCT04229563
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- PATHFINDER Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (EX-PAD-05)
- Conditions
- Infrainguinal Peripheral Artery Disease
- Peripheral Arterial Disease
- PAD
- Interventions
- Device: AURYON Atherectomy System
- Sponsor
- Angiodynamics, Inc.
- Start date
- 2020-08-04
- Primary completion
- 2021-03-17
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 10
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Subject is ≥ 18 years old. 2. Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease. 3. Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ). 4. Subject is capable and willing to comply with the scheduled follow up 5. Subject is able and willing to sign a written Informed Consent Form (ICF). Exclusion Criteria: 1. Target lesion is in an arterial bypass. 2. Planned use of another atherectomy device in the same procedure 3. 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. 4. Participating in another study on an interventional non-cleared device, that could impact the study results
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04229563