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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229563
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Brief 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.

Condition or disease Intervention/treatment
Infrainguinal Peripheral Artery Disease Device: AURYON™ System

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PATHFINDER I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-Registry, EX-PAD-05)
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study patients
Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
Device: AURYON™ System
The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.




Primary Outcome Measures :
  1. Primary Efficacy: Acute Procedural Success [ Time Frame: Through discharge, an average of 8 weeks ]
    Percentage of subjects with successful revascularization of target vessel defined as ≤30% residual stenosis at the index lesion post AURYON™ atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with infra-inguinal PAD undergoing atherectomy with the AURYON™ Atherectomy System.
Criteria

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 2-6 ).
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229563


Contacts
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Contact: Alicia Conway 7742498707 aconway@angiodynamics.com

Sponsors and Collaborators
Angiodynamics, Inc.

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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT04229563    
Other Study ID Numbers: EX-PAD-05
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases