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

NCT04229563 | Unknown FDA Device

• 1 other identifier: EX-PAD-05
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 5

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.

Conditions

Infrainguinal Peripheral Artery Disease; Peripheral Arterial Disease; PAD

Keywords

Peripheral Artery Disease; Peripheral Occlusive Disease; Peripheral Artery Stenonsis; Artery Restenosis; Arterial Occlusive Disease; Peripheral Vascular disease; Laser recanalization; Endovascular treatment or Procedure or Surgery; Calcified Lesions; Atherectomy; Intermittent Claudication; Claudication pain; Arterial Calcification; Critical Limb Ischemia; CLI; Acute Limb Ischemia; Acute Arterial Occlusion; Infra-inguinal Stenosis or Occlusion; Femoral Artery Stenosis; Femoral-Popliteal Arterial Disease; Tibial Stenosis; In-stent Restenosis; Stenotic lesion; Peripheral Artery Revascularization; Lower Limb Arterial Calcification; Laser-assisted angioplasty; Above the Knee calcification; ATK Calcification; Below the Knee Calcification; Chronic total occlusion; CTO; Superficial Femoral Artery Disease; Target Lesion revascularization; Atherectomy Catheter; Observational Study; Registry; Walking Impairment questionnaire; Intravascular ultrasound; Ankle-Brachial Pressure Index; Toe-Brachial Index; Rutherford Classification; ABI; TBI; Peak Systolic Velocity Ratio; Auryon System; Eximo Medical; AngioDynamics; B-Laser; Real World Evidence

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy: Acute Procedural Success

  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.

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

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

  Percentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge.

  Till discharge, an average of 5 days

Secondary Outcomes (7)

• Rate of device related complications requiring intervention

  Till discharge, an average of 5 days

• Rates of MAEs over time

  Post-discharge (at 30-days, 6-, 12-, and 24-months)

• Patency rate

  Post-discharge (at 6-, 12-, and 24-months)

• Occlusion freedom

  Post-discharge (at 6-, 12-, and 24-months)

• Clinical outcome 1 - ankle brachial index (ABI)

  Post-discharge (at 6-, 12-, and 24-months)

Other Outcomes (1)

• Exploratory endpoint: IVUS

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

Study Arms (1)

Study patients

Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.

Device: AURYON™ System

Interventions

AURYON™ System DEVICE

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

Study patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with infra-inguinal PAD undergoing atherectomy with the AURYON™ Atherectomy System.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (5)

Pulse Cardiovacular

Scottsdale, Arizona, 85259, United States

Location

Pima Vascular

Tucson, Arizona, 85718, United States

Location

Comprehensive Cardiovascular

Davenport, Florida, 33837, United States

Location

Midwest Cardio. research foundation

Davenport, Iowa, 52803, United States

Location

Hurricane Cardiology

New Braunfels, Texas, 78130, United States

Location

Related Publications (1)

• Das TS, Shammas NW, Yoho JA, Martinez-Clark P, Ramaiah V, Leon LR, Pacanowski JP, Tai Z, Ali V, Arslan B, Rundback J. Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry. Catheter Cardiovasc Interv. 2024 May;103(6):949-962. doi: 10.1002/ccd.31023. Epub 2024 Apr 2.

  PMID: 38566525 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Intermittent Claudication; Chronic Limb-Threatening Ischemia; Bites and Stings

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• TBD TBD

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: August 4, 2020
• Primary Completion: March 17, 2021
• Study Completion: April 17, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

US (5)