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Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease

United States104 participantsStarted 2020-08-04

Plain-language summary

The PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study. It is a pilot registry study towards a subsequent large pivotal phase registry. 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Primary Efficacy: Acute Procedural Success

Timeframe: Peri-procedural (by the end of the index procedure)

Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE)

Timeframe: Till discharge, an average of 5 days

Trial details

NCT IDNCT04229563

SponsorAngiodynamics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-03-17

View on ClinicalTrials.gov More Infrainguinal Peripheral Artery Disease trials