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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Angiodynamics, Inc.
Study ID
NCT04229563
Status
Completed

Conditions

  • Infrainguinal Peripheral Artery Disease
  • PAD
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AURYON Atherectomy System — DEVICE
    The AURYON Atherectomy System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.

Study Details

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.

Key Dates

Start date
Aug 4, 2020
Status verified
Apr 2026
Primary completion
Mar 17, 2021
Completion
Apr 17, 2023

Study Design

Enrollment
102 participants (actual)

Arms

  • Arm: Study patients
    Eligible PAD patients who are routinely treated with atherectomy by AURYON Atherectomy System.

Primary Outcome Measure

Primary Efficacy: Acute Procedural Success [ Time Frame: Peri-procedural (by the end of the index procedure) ]

Locations (10)

FacilityCityStateZIPSite coordinators
Pulse CardiovacularScottsdaleArizona85259-
Pima VascularTucsonArizona85718-
Comprehensive CardiovascularDavenportFlorida33837-
First Coast Cardiovascular InstituteJacksonvilleFlorida32256-
Amavita Clinical ResearchMiamiFlorida33169-
Rush University Medical CenterChicagoIllinois60612-
Midwest Cardio. research foundationDavenportIowa52803-
NJ Endovascular Amputation PreventionCliftonNew Jersey07013-
Medical City Heart and SpineDallasTexas75243-
Hurricane CardiologyNew BraunfelsTexas78130-

Find similar trials in Scottsdale, AZ

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
Pulse Cardiovacular· Scottsdale, AZPima Vascular· Tucson, AZComprehensive Cardiovascular· Davenport, FLFirst Coast Cardiovascular Institute· Jacksonville, FLAmavita Clinical Research· Miami, FLRush University Medical Center· Chicago, IL

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